Trial Outcomes & Findings for Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (NCT NCT01167712)

NCT ID: NCT01167712

Last Updated: 2025-11-14

Results Overview

First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 692 participants
• Primary outcome timeframe: The timeframe is from enrollment onto the study up to 3 years following enrollment.
• Results posted on: 2025-11-14

Participant Flow

Newly diagnosed women with high-risk early stage or advanced stage epithelial ovarian cancer enrolled from September 27, 2010 to February 8, 2012.These women were randomly assigned to receive either carboplatin (AUC 6) combined with either paclitaxel 175 mg/m2 q 21 days or paclitaxel 80mg/m2 on days 1, 8 and 15. Bevacizumab was optional.

112 additional women, whose treatment was not randomized, enrolled onto this study in order to evaluate whether findings from perfusion imaging are prognostic. This report focuses on the randomized treatment component of this study.

Participant milestones

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Arm II (Neoadjuvant Chemotherapy) Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Study STARTED	346	346
Overall Study COMPLETED	346	346
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Baseline characteristics by cohort

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) n=346 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Neoadjuvant Chemotherapy) n=346 Participants Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery	Total n=692 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	214 Participants n=10 Participants	217 Participants n=10 Participants	431 Participants n=20 Participants
Age, Categorical >=65 years	132 Participants n=10 Participants	129 Participants n=10 Participants	261 Participants n=20 Participants
Sex: Female, Male Female	346 Participants n=10 Participants	346 Participants n=10 Participants	692 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Region of Enrollment Canada	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Region of Enrollment United States	345 Participants n=10 Participants	345 Participants n=10 Participants	690 Participants n=20 Participants
Region of Enrollment South Korea	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants

PRIMARY outcome

Timeframe: The timeframe is from enrollment onto the study up to 3 years following enrollment.

Population: Whole sample

First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) n=346 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Arm II (Neoadjuvant Chemotherapy) n=346 Participants Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Progression-Free Survival	14.7 months Interval 13.5 to 15.8	14.0 months Interval 12.7 to 15.2

SECONDARY outcome

Timeframe: The timeframe is from enrollment onto the study up to 3 years after enrollment

Population: Whole sample

First Quartile Overall Survival

Outcome measures

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) n=346 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Arm II (Neoadjuvant Chemotherapy) n=346 Participants Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Median Duration of First Quartile Survival	23.2 months Interval 20.1 to 26.3	24 months Interval 19.8 to 26.0

SECONDARY outcome

Timeframe: 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

Population: All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.

Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)

Outcome measures

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) n=292 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Arm II (Neoadjuvant Chemotherapy) n=287 Participants Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)	70.9 Units on a Scale Standard Error 1.42	68.2 Units on a Scale Standard Error 1.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (T0) up to 10 days after the start of course 2 (T2)

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Adjuvant Chemotherapy Suboptimally Debulked)

Serious events: 122 serious events

Other events: 343 other events

Deaths: 0 deaths

Arm II (Neoadjuvant Chemotherapy)

Serious events: 167 serious events

Other events: 340 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) n=346 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Arm II (Neoadjuvant Chemotherapy) n=346 participants at risk Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Cardiac disorders Acute Coronary Syndrome	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Ventricular Fibrillation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Ventricular Arrhythmia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Paroxysmal Atrial Tachycardia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Dry Eye	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Retinal Detachment	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Obstruction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Perforation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Fistula	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colitis	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Constipation	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Diarrhea	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Duodenal Perforation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Vomiting	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Small Intestinal Obstruction	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Abdominal Pain	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Obstruction Gastric	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Ileal Perforation	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Ileal Obstruction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Ileal Fistula	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Retroperitoneal Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Nausea	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Ulcer	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Perforation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Esophageal Ulcer	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Esophagitis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Jejunal Obstruction	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Multi-Organ Failure	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Malaise	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Non-Cardiac Chest Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Fatigue	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Death Nos	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Fever	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Infusion Related Reaction	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Hepatobiliary disorders Portal Vein Thrombosis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Infections And Infestations - Other	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Wound Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Tooth Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Splenic Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Skin Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Sepsis	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Pleural Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Pelvic Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Lung Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Kidney Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Endocarditis Infective	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Device Related Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Hemolytic Uremic Syndrome	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Anemia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Febrile Neutropenia	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Atrial Fibrillation	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Cardiac Arrest	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Myocardial Infarction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Left Ventricular Systolic Dysfunction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Seroma	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Stomal Ulcer	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Hip Fracture	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Wound Complication	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Platelet Count Decreased	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Neutrophil Count Decreased	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypokalemia	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Dehydration	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Joint Effusion	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Bone Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Abdominal Soft Tissue Necrosis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Renal And Urinary Disorders - Other	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Tract Obstruction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Renal Calculi	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Proteinuria	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Acute Kidney Injury	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Urinary Tract Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Catheter Related Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Enterocolitis Infectious	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Bladder Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Anorectal Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Abdominal Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Thromboembolic Event	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Peripheral Ischemia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hypotension	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hypertension	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hematoma	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Ulceration	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Surgical and medical procedures Surgical And Medical Procedures - Other	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Transient Ischemic Attacks	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Stroke	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Seizure	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Intracranial Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Headache	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Syncope	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Dizziness	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Depression	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Confusion	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Anxiety	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.

Other adverse events

Measure	Arm I (Adjuvant Chemotherapy Suboptimally Debulked) n=346 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Arm II (Neoadjuvant Chemotherapy) n=346 participants at risk Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Ear and labyrinth disorders Ear Pain	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Ear and labyrinth disorders External Ear Inflammation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Endocrine disorders Adrenal Insufficiency	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Endocrine disorders Hypothyroidism	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Endocrine disorders Hyperthyroidism	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Endocrine disorders Endocrine Disorders - Other	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Endocrine disorders Cushingoid	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Eye Disorders - Other	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Watering Eyes	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Flashing Lights	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Eye Pain	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Glaucoma	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Cataract	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Photophobia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Conjunctivitis	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Retinal Vascular Disorder	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Blurred Vision	13.6% 47/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	14.7% 51/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Dry Eye	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Floaters	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Eye disorders Vitreous Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Enterocolitis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Dysphagia	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Dyspepsia	6.1% 21/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	8.1% 28/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Dry Mouth	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Obstruction	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Perforation	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Fistula	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colitis	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Colonic Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Constipation	65.3% 226/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	61.8% 214/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Diarrhea	42.2% 146/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	44.2% 153/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Vomiting	38.4% 133/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	33.2% 115/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Bloating	9.2% 32/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.1% 21/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Stomach Pain	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Salivary Duct Inflammation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Small Intestinal Obstruction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Anal Hemorrhage	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Ulcer	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Anal Mucositis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Mucositis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Abdominal Pain	40.2% 139/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	39.9% 138/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Proctitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Thrombotic Thrombocytopenic Purpura	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Lymph Node Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Leukocytosis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders - Other	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Anemia	93.6% 324/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	97.1% 336/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Periodontal Disease	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Hemorrhage	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Oral Dysesthesia	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Bone Marrow Hypocellular	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Blood and lymphatic system disorders Febrile Neutropenia	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Atrial Fibrillation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Ventricular Tachycardia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Sinus Bradycardia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Palpitations	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Left Ventricular Systolic Dysfunction	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Acute Coronary Syndrome	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Ventricular Fibrillation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Cardiac Disorders - Other	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Pericardial Effusion	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Ventricular Arrhythmia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Paroxysmal Atrial Tachycardia	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Sinus Tachycardia	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Cardiac disorders Chest Pain - Cardiac	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Ear and labyrinth disorders Middle Ear Inflammation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Ear and labyrinth disorders Vertigo	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Ear and labyrinth disorders Tinnitus	8.1% 28/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Ear and labyrinth disorders Hearing Impaired	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Anal Pain	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Oral Hemorrhage	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Ileus	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Ileal Fistula	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Anal Ulcer	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Pain	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Hemorrhage	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gingival Pain	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Oral Pain	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Abdominal Distension	7.2% 25/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Nausea	69.1% 239/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	62.1% 215/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastroparesis	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Ulcer	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastroesophageal Reflux Disease	6.1% 21/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	7.8% 27/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Rectal Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Lip Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastric Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Esophageal Ulcer	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Esophagitis	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Fecal Incontinence	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Hemorrhoidal Hemorrhage	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Hemorrhoids	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Ascites	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Toothache	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Jejunal Obstruction	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Anal Fistula	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Mucositis Oral	22.0% 76/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	26.9% 93/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastrointestinal Disorders - Other	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Flatulence	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Gastritis	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Duodenal Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Device Related Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Conjunctivitis Infective	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders General Disorders And Administration Site Conditio	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Gum Infection	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Vaginal Infection	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Urinary Tract Infection	12.7% 44/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	15.0% 52/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Catheter Related Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Bronchial Infection	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Enterocolitis Infectious	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Pain	26.9% 93/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	24.9% 86/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Neck Edema	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Malaise	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Localized Edema	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Irritability	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Injection Site Reaction	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Infusion Site Extravasation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Flu Like Symptoms	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Edema Trunk	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Non-Cardiac Chest Pain	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Edema Limbs	15.6% 54/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	18.8% 65/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Facial Pain	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Edema Face	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Fatigue	84.7% 293/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	86.7% 300/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Fever	7.5% 26/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	11.0% 38/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Gait Disturbance	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Chills	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.6% 23/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
General disorders Infusion Related Reaction	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Hepatobiliary disorders Hepatobiliary Disorders - Other	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Hepatobiliary disorders Hepatic Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Hepatobiliary disorders Portal Vein Thrombosis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Immune system disorders Allergic Reaction	5.2% 18/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Immune system disorders Cytokine Release Syndrome	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Immune system disorders Immune System Disorders - Other	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Infections And Infestations - Other	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Wound Infection	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Upper Respiratory Infection	5.5% 19/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Tooth Infection	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Stoma Site Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Vulval Infection	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Skin Infection	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Sinusitis	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Sepsis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Salivary Gland Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Rhinitis Infective	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Rash Pustular	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Pleural Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Pharyngitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Peritoneal Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Peripheral Nerve Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Otitis Media	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Papulopustular Rash	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Otitis Externa	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Nail Infection	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Mucosal Infection	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Pelvic Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Lung Infection	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Laryngitis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Kidney Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Hepatitis Viral	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Eye Infection	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Esophageal Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Esophageal Pain	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Gastrointestinal disorders Dental Caries	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypokalemia	17.3% 60/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	19.1% 66/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypoglycemia	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypocalcemia	8.1% 28/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	13.9% 48/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	14.2% 49/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	18.8% 65/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hyperuricemia	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypernatremia	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypermagnesemia	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hyperkalemia	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hyperglycemia	21.1% 73/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	23.7% 82/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypercalcemia	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Glucose Intolerance	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Dehydration	10.4% 36/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	11.0% 38/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Anorexia	29.5% 102/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	33.5% 116/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Acidosis	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Superficial Soft Tissue Fibrosis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Pain In Extremity	23.1% 80/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	19.9% 69/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Neck Pain	6.1% 21/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Myositis	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Myalgia	26.3% 91/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	21.7% 75/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal Deformity	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Upper Limb	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Trunk	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Right-Sided	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness Left-Sided	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased Cervical Spine	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Joint Effusion	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	10.1% 35/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	12.7% 44/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Flank Pain	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Chest Wall Pain	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Trismus	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Buttock Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Bone Pain	9.5% 33/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	7.2% 25/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Back Pain	20.2% 70/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	15.6% 54/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Arthritis	5.5% 19/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.2% 18/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	34.4% 119/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	24.0% 83/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Frequency	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	9.8% 34/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Fistula	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Renal Calculi	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Proteinuria	13.6% 47/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	15.9% 55/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Hematuria	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Cystitis Noninfective	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Chronic Kidney Disease	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Bladder Spasm	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Acute Kidney Injury	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Reproductive System And Breast Disorders - Other	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Pain	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Hemorrhage	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Fistula	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Dryness	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Perineal Pain	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Pelvic Pain	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Menorrhagia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Discharge	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Vaginal Inflammation	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Genital Edema	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Dyspareunia	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Reproductive system and breast disorders Breast Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Bladder Infection	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Lip Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Anorectal Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Infections and infestations Abdominal Infection	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders - Other	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypophosphatemia	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.4% 22/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hyponatremia	16.5% 57/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	18.2% 63/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Metabolism and nutrition disorders Hypomagnesemia	19.7% 68/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	24.9% 86/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal Hemorrhage	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	12.1% 42/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	13.0% 45/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal Hemorrhage	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	7.2% 25/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.7% 89/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	37.9% 131/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	34.7% 120/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	37.9% 131/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Cough	22.0% 76/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	26.0% 90/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	11.3% 39/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	13.3% 46/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	8.1% 28/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	9.5% 33/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Urticaria	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Ulceration	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Induration	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Scalp Pain	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Rash Acneiform	5.2% 18/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Purpura	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Pruritus	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.4% 22/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Photosensitivity	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Periorbital Edema	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Lymphocele	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Lymphedema	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hypotension	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hypertension	39.3% 136/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	35.3% 122/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hot Flashes	12.7% 44/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	11.3% 39/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Pain Of Skin	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Hematoma	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	12.4% 43/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	21.4% 74/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Flushing	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Nail Ridging	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Nail Loss	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Nail Discoloration	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	9.5% 33/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Hypertrichosis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Erythroderma	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Erythema Multiforme	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Dry Skin	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	10.4% 36/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Bullous Dermatitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Body Odor	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Skin and subcutaneous tissue disorders Alopecia	74.6% 258/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	67.9% 235/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Social circumstances Social Circumstances - Other	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Social circumstances Menopause	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Surgical and medical procedures Surgical And Medical Procedures - Other	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Vascular Disorders - Other	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Thromboembolic Event	6.6% 23/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.1% 21/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Superficial Thrombophlebitis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Phlebitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Vascular disorders Peripheral Ischemia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Memory Impairment	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Lethargy	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Movements Involuntary	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Hypersomnia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Headache	33.5% 116/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	32.4% 112/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Facial Nerve Disorder	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Extrapyramidal Disorder	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Radiculitis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Encephalopathy	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Dysphasia	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Dysgeusia	12.1% 42/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	16.8% 58/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Sinus Pain	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Dysesthesia	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Dysarthria	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Syncope	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Dizziness	17.6% 61/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	19.1% 66/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Concentration Impairment	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Cognitive Disturbance	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Ataxia	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Amnesia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Akathisia	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Psychiatric Disorders - Other	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Suicidal Ideation	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Psychosis	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Restlessness	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Libido Decreased	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Insomnia	26.0% 90/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	24.6% 85/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Depression	19.1% 66/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	19.1% 66/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Delirium	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Confusion	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Anxiety	17.3% 60/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	19.7% 68/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Psychiatric disorders Agitation	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Renal And Urinary Disorders - Other	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urine Discoloration	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Urgency	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.2% 11/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Tract Obstruction	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Retention	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Incontinence	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Renal and urinary disorders Urinary Tract Pain	4.6% 16/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.2% 18/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Intraoperative Musculoskeletal Injury	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Burn	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Bruising	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Ankle Fracture	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Investigations - Other	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.0% 14/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Weight Loss	16.2% 56/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	13.9% 48/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Weight Gain	15.3% 53/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	11.3% 39/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Serum Amylase Increased	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Platelet Count Decreased	74.3% 257/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	79.2% 274/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Pancreatic Enzymes Decreased	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Lymphocyte Count Decreased	5.2% 18/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	10.4% 36/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Lipase Increased	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Inr Increased	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Hemoglobin Increased	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Ggt Increased	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Ejection Fraction Decreased	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Creatinine Increased	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	9.8% 34/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Cholesterol High	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Neutrophil Count Decreased	93.9% 325/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	95.7% 331/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Urine Output Decreased	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Cardiac Troponin I Increased	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Cpk Increased	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Blood Bilirubin Increased	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations White Blood Cell Decreased	92.8% 321/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	96.0% 332/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Aspartate Aminotransferase Increased	11.6% 40/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	12.1% 42/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Alkaline Phosphatase Increased	11.8% 41/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	13.6% 47/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Alanine Aminotransferase Increased	11.0% 38/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	11.3% 39/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Investigations Activated Partial Thromboplastin Time Prolonged	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Injury, Poisoning And Procedural Complications - O	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Wrist Fracture	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Wound Dehiscence	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.0% 7/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Vascular Access Complication	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Vaginal Anastomotic Leak	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Spinal Fracture	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Seroma	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Tracheal Obstruction	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Intestinal Stoma Site Bleeding	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Stomal Ulcer	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Fracture	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Fall	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Injury, poisoning and procedural complications Wound Complication	4.9% 17/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.8% 13/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder -	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.3% 8/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Including cysts and polyps	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Nervous System Disorders - Other	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Tremor	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Transient Ischemic Attacks	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Somnolence	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Reversible Posterior Leukoencephalopathy Syndrome	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Presyncope	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Peripheral Sensory Neuropathy	70.5% 244/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	67.3% 233/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Peripheral Motor Neuropathy	5.5% 19/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	5.8% 20/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Paresthesia	5.5% 19/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Nystagmus	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Nervous system disorders Neuralgia	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	1.4% 5/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	1.7% 6/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Voice Alteration	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	4.3% 15/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sore Throat	7.8% 27/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	7.2% 25/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	1.2% 4/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	2.9% 10/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	6.4% 22/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	6.9% 24/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.00% 0/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.5% 12/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	2.6% 9/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.87% 3/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal Mucositis	0.29% 1/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.	0.58% 2/346 • AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.

Additional Information

Linda Gedeon for Mark Brady, PhD.

NRG Oncology

Phone: 716-845-1169

Email: lgedeon@gogstats.org

Results disclosure agreements

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

Restriction type: LTE60