Trial Outcomes & Findings for Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer (NCT NCT00262821)

NCT ID: NCT00262821

Last Updated: 2019-07-23

Results Overview

Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 402 participants
• Primary outcome timeframe: From study entry until first disease progression, death or date of last contact, up to 6 years
• Results posted on: 2019-07-23

Participant Flow

Eligible and evaluable patients.

Participant milestones

Measure	Concurrent Cisplatin and Radiation Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Overall Study STARTED	198	204
Overall Study COMPLETED	194	185
Overall Study NOT COMPLETED	4	19

Reasons for withdrawal

Measure	Concurrent Cisplatin and Radiation Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Overall Study Ineligible - wrong stage	0	3
Overall Study Ineligible - wrong cell type	2	2
Overall Study Ineligible - wrong primary	0	1
Overall Study Ineligible - inadequate pathology	1	3
Overall Study Ineligible - elevated creatinine	0	2
Overall Study Ineligible - required test not done	1	4
Overall Study Inevaluable - inadequate data	0	4

Baseline Characteristics

Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

Baseline characteristics by cohort

Measure	Concurrent Cisplatin and Radiation n=194 Participants Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation n=185 Participants Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Total n=379 Participants Total of all reporting groups
Cooperative Group Enrollment Gynecologic Oncology Group (GOG)	167 participants n=5 Participants	167 participants n=7 Participants	334 participants n=5 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 11.3 • n=5 Participants	48.4 years STANDARD_DEVIATION 11.3 • n=7 Participants	48.7 years STANDARD_DEVIATION 11.3 • n=5 Participants
Age, Customized 20-30 years	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Age, Customized 31-40 years	41 participants n=5 Participants	37 participants n=7 Participants	78 participants n=5 Participants
Age, Customized 41-50 years	65 participants n=5 Participants	61 participants n=7 Participants	126 participants n=5 Participants
Age, Customized 51-60 years	53 participants n=5 Participants	48 participants n=7 Participants	101 participants n=5 Participants
Age, Customized 61-70 years	20 participants n=5 Participants	23 participants n=7 Participants	43 participants n=5 Participants
Age, Customized 71-79 years	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Sex: Female, Male Female	194 Participants n=5 Participants	185 Participants n=7 Participants	379 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	161 Participants n=5 Participants	138 Participants n=7 Participants	299 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	23 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Cooperative Group Enrollment National Cancer Institute of Canada (NCIC)	24 participants n=5 Participants	17 participants n=7 Participants	41 participants n=5 Participants
Cooperative Group Enrollment Other	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	30 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants	134 Participants n=7 Participants	263 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Gynecologic Oncology Group (GOG) Performance Status 0 - fully active	147 participants n=5 Participants	141 participants n=7 Participants	288 participants n=5 Participants
Gynecologic Oncology Group (GOG) Performance Status 1 - restricted strenuous activity, ambulatory	46 participants n=5 Participants	41 participants n=7 Participants	87 participants n=5 Participants
Gynecologic Oncology Group (GOG) Performance Status 2 - ambulatory, difficulty walking	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Gynecologic Oncology Group (GOG) Performance Status 3 - limited self-care, partly confined to bed	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Gynecologic Oncology Group (GOG) Performance Status 4 - completely disabled, no self-care	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Tumor Grade 1 - Well differentiated	8 participants n=5 Participants	12 participants n=7 Participants	20 participants n=5 Participants
Tumor Grade 2 - Moderately differentiated	105 participants n=5 Participants	103 participants n=7 Participants	208 participants n=5 Participants
Tumor Grade 3 - Poorly differentiated	78 participants n=5 Participants	67 participants n=7 Participants	145 participants n=5 Participants
Tumor Grade Not graded	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin IB	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin IIA	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin IIB	93 participants n=5 Participants	82 participants n=7 Participants	175 participants n=5 Participants
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin IIIB	51 participants n=5 Participants	52 participants n=7 Participants	103 participants n=5 Participants
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin IVA	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Histologic Type Squamous cell carcinoma	164 participants n=5 Participants	158 participants n=7 Participants	322 participants n=5 Participants
Histologic Type Adenocarcinoma, unspecified	15 participants n=5 Participants	18 participants n=7 Participants	33 participants n=5 Participants
Histologic Type Adenosquamous carcinoma	11 participants n=5 Participants	5 participants n=7 Participants	16 participants n=5 Participants
Histologic Type Other	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Para-aortic Lymph Node Not sampled	25 participants n=5 Participants	33 participants n=7 Participants	58 participants n=5 Participants
Para-aortic Lymph Node Sampled	169 participants n=5 Participants	152 participants n=7 Participants	321 participants n=5 Participants
Brachytherapy None	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Brachytherapy Low-dose rate	52 participants n=5 Participants	51 participants n=7 Participants	103 participants n=5 Participants
Brachytherapy High-dose rate	138 participants n=5 Participants	129 participants n=7 Participants	267 participants n=5 Participants

PRIMARY outcome

Timeframe: From study entry until first disease progression, death or date of last contact, up to 6 years

Population: Eligible and evaluable patients

Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.

Outcome measures

Measure	Concurrent Cisplatin and Radiation n=194 Participants Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation n=185 Participants Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Progression-free Survival - Percentage of Patients Alive and Progression Free	64.4 percentage of patients	63.0 percentage of patients

SECONDARY outcome

Timeframe: From study entry to death or last contact, up to 6 years

Population: Eligible and evaluable patients

The observed length of life from entry into the study to death or date of last contact.

Outcome measures

Measure	Concurrent Cisplatin and Radiation n=194 Participants Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation n=185 Participants Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Overall Survival	70.6 percentage of patients alive	70.5 percentage of patients alive

SECONDARY outcome

Timeframe: All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported

Population: All Treated Patients

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.

Outcome measures

Measure	Concurrent Cisplatin and Radiation n=190 Participants Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation n=180 Participants Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Adverse Events (Grade 3 or Higher) During Treatment Period Leukopenia	51 participants	53 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Thrombocytopenia	8 participants	6 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Neutropenia	30 participants	26 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Anemia	16 participants	12 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Other hematologic	20 participants	17 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Allergy/Immunology	0 participants	2 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Cardiac	3 participants	4 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Coagulation	0 participants	1 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Constitutional	15 participants	23 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Dermatologic	0 participants	17 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Gastrointestinal	28 participants	35 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Genitourinary/Renal	4 participants	4 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Hemorrhage	5 participants	5 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Infection	14 participants	14 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Metabolic	28 participants	45 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Musculoskeletal	0 participants	5 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Neuropathy	1 participants	1 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Other Neurological	5 participants	14 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Pain	10 participants	38 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Pulmonary	3 participants	6 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Vascular Disorders	11 participants	7 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Death, Not CTC Coded	4 participants	0 participants
Adverse Events (Grade 3 or Higher) During Treatment Period Number Participants Analyzed	190 participants	180 participants

Adverse Events

Concurrent Cisplatin and Radiation

Serious events: 42 serious events

Other events: 187 other events

Deaths: 0 deaths

Concurrent Cisplatin, Tirapazamine and Radiation

Serious events: 65 serious events

Other events: 179 other events

Deaths: 0 deaths

Serious adverse events

Measure	Concurrent Cisplatin and Radiation n=190 participants at risk Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation n=180 participants at risk Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Immune system disorders Allergic Reaction/Hypersensitivity	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Ear and labyrinth disorders Hearing (Without Monitoring Program)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Neutrophils	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Platelets	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Leukocytes	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Lymphopenia	2.6% 5/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Hemoglobin	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders S/N Arrhythmia: Sinus Bradycardia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Ventricular Arrhythmia - Fibrillation	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Cardiac General - Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Fever	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Fatigue	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Death No Ctcae Term - Death Nos	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Death No Ctcae Term - Multi-Organ Failure	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Rash	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Obstruction, Gi - Ileum	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Ulcer,gi - Esophagus	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Distention	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Colitis	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Vomiting	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Anorexia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Dehydration	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Nausea	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Stricture, Gi - Rectum	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Diarrhea	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Vagina	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Uterus	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Bladder	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage/Bleeding - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Hepatobiliary disorders Liver Dysfunction	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Blood	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Blood	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Febrile Neutropenia	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Infection - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Rectum	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Creatinine	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Alt	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypokalemia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Syncope	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Mood Alteration - Depression	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Mood Alteration - Anxiety	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Cognitive Disturbance	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Pelvis	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Chest /Thorax Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Back	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Abdominal Pain Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Cardiac/ Heart	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Muscle	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Ards	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Renal/Genitourinary - Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Obstruction, Gu - Ureter	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Renal Failure	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Urinary Frequency	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Vascular - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Artery Injury - Aorta	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Thrombosis/Embolism (Vascular Access-Related)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Thrombosis/Thrombus/Embolism	4.2% 8/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.

Other adverse events

Measure	Concurrent Cisplatin and Radiation n=190 participants at risk Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium	Concurrent Cisplatin, Tirapazamine and Radiation n=180 participants at risk Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Immune system disorders Allergy/Immunology - Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Immune system disorders Allergic Reaction/Hypersensitivity	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Immune system disorders Rhinitis	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Ear and labyrinth disorders Auditory/Ear - Other	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Ear and labyrinth disorders Hearing (Without Monitoring Program)	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Ear and labyrinth disorders Tinnitus	11.6% 22/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	13.9% 25/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Ear and labyrinth disorders Hearing (Monitoring Program)	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Neutrophils	45.3% 86/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	43.3% 78/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Platelets	38.4% 73/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	36.7% 66/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Blood/Bone Marrow - Other	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Leukocytes	73.2% 139/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	71.1% 128/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Lymphopenia	11.1% 21/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	8.9% 16/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Hemoglobin	80.5% 153/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	75.0% 135/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Palpitations	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Ventricular Arrhythmia - Tachycardia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders S/N Arrhythmia: Sinus Tachycardia	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Supraventricular Tachycardia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders S/N Arrhythmia:supraventricular Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders S/N Arrhythmia: Sinus Bradycardia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Ventricular Arrhythmia - Pvcs	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Ventricular Arrhythmia - Trigeminny	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders S/N Arrhythmia: Atrial Tachycardia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Cardiac Ischemia/Infarction	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Hypertension	5.3% 10/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Cardiac General - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Cardiac Troponin T (Ctnt)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Cardiac disorders Hypotension	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Inr	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Constitutional Symptoms - Other	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Sweating	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Weight Gain	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Fever	6.3% 12/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	5.6% 10/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Weight Loss	18.4% 35/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	23.9% 43/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Rigors/Chills	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Fatigue	73.7% 140/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	74.4% 134/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Insomnia	11.6% 22/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	11.7% 21/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Nail Changes	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Injection Site Reaction	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	6.3% 12/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.8% 14/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Dermatitis - Chemoradiation	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Wound Complication, Non-Infectious	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Bruising	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Acne	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Rash	6.3% 12/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	23.9% 43/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Dry Skin	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Decubitus	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Dermatitis - Radiation	13.7% 26/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	12.8% 23/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Pruritus	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.2% 13/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Burn	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Flushing	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	2.6% 5/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.9% 7/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	4.4% 8/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Endocrine disorders Hot Flashes	11.1% 21/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	6.7% 12/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Enteritis	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Obstruction, Gi - Ileum	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Proctitis	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Flatulence	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Gastritis	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Esophagitis	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Hemorrhoids	3.7% 7/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Heartburn	10.0% 19/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.2% 13/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Perforation, Gi - Rectum	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Ileus	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Dysphagia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Distention	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Taste Alteration	14.7% 28/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	15.0% 27/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Incontinence, Anal	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Dry Mouth	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	4.4% 8/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Rectum	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	5.0% 9/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Colitis	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Necrosis, Gi - Rectum	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	4.2% 8/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	5.6% 10/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Vomiting	39.5% 75/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	59.4% 107/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Anorexia	31.1% 59/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	33.3% 60/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Dehydration	3.7% 7/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	10.6% 19/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Constipation	26.3% 50/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	26.1% 47/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Nausea	66.8% 127/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	74.4% 134/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Gastrointestinal - Other	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Gastrointestinal disorders Diarrhea	62.6% 119/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	62.2% 112/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Urinary Nos	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Vagina	20.5% 39/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	15.6% 28/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gi - Rectum	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage/Pulmonary - Nose	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hematoma	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gi - Anus	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Uterus	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gi - Oral Cavity	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Kidney	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage, Gu - Bladder	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Petechiae	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Hemorrhage/Bleeding - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Hepatobiliary disorders Hepatobiliary/Pancreas - Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Blood	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Artery	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vulva	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Cervix	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Blood	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Wound	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Febrile Neutropenia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Nerve-Peripheral	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Colon	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	5.3% 10/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	8.3% 15/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Infection - Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Bronchus	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Urinary Tract Nos	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Bladder (Urinary)	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Rectum	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf Unknown Anc: Skin (Cellulitis)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Edema: Trunk/Genital	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Edema: Limb	6.3% 12/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.2% 13/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Blood and lymphatic system disorders Edema: Head And Neck	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Ast	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	11.1% 20/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Gfr	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	4.4% 8/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Proteinuria	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Creatinine	11.6% 22/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	11.7% 21/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypoalbuminemia	11.6% 22/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	20.6% 37/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Ggt	2.6% 5/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.9% 7/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Alt	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	15.0% 27/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Alkaline Phosphatase	4.2% 8/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	9.4% 17/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Bilirubin	2.6% 5/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Lipase	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypermagnesemia	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypophosphatemia	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hyponatremia	21.1% 40/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	25.6% 46/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Bicarbonate, Serum-Low	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Amylase	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Acidosis	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypernatremia	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypocalcemia	16.8% 32/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	20.6% 37/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hyperkalemia	3.7% 7/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.9% 7/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hyperglycemia	24.2% 46/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	33.9% 61/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypokalemia	21.1% 40/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	33.9% 61/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypoglycemia	4.2% 8/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypercalcemia	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Metabolism and nutrition disorders Hypomagnesemia	27.4% 52/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	28.3% 51/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Myositis	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Musculoskeletal/St: Other	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.8% 14/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Osteoporosis	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Joint-Function	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Arthritis	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	5.3% 10/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Neuropathy,cranial - Cn X Motor-Palate	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Syncope	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Involuntary Movement	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Psychosis	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Neurology - Other	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Encephalopathy	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Mood Alteration - Depression	9.5% 18/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	6.7% 12/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Mood Alteration - Anxiety	7.9% 15/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	10.0% 18/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Mood Alteration - Agitation	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Tremor	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Personality	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Somnolence	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Confusion	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Memory Impairment	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Dizziness	10.5% 20/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	12.2% 22/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Neuropathy,cranial - Cn I Smell	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Neuropathy-Sensory	16.3% 31/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	16.7% 30/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Nervous system disorders Neuropathy-Motor	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	6.7% 12/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Eye disorders Ocular/Visual - Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Eye disorders Dry Eye	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Eye disorders Photophobia	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Eye disorders Flashing Lights/Floaters	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.8% 5/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Eye disorders Diplopia	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Eye disorders Blurred Vision	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	6.1% 11/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain - Other	4.7% 9/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	6.7% 12/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Urethra	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	5.6% 10/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Perineum	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Pelvis	14.2% 27/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	15.6% 28/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Vagina	5.8% 11/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Uterus	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Chest /Thorax Nos	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.3% 6/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Chest Wall	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Throat/Pharynx/Larynx	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Head/Headache	13.2% 25/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	8.3% 15/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Neck	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Extremity-Limb	6.8% 13/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	15.6% 28/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Buttock	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Back	12.1% 23/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	11.7% 21/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Joint	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Bone	2.1% 4/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Kidney	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Bladder	4.7% 9/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.9% 7/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Pain Nos	2.6% 5/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Stomach	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.7% 3/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Rectum	2.6% 5/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	3.9% 7/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Peritoneum	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Oral Cavity	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Esophagus	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Dental/Teeth/Peridontal	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Abdominal Pain Nos	27.4% 52/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	20.0% 36/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Cardiac/ Heart	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Tumor	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Muscle	6.3% 12/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	26.7% 48/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Anus	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Pain: Neuralgia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Voice Changes	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Hiccoughs	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 11/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	4.4% 8/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.9% 15/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	8.3% 15/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Renal/Genitourinary - Other	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Stricture, Anastomotic, Gu - Urethra	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Stricture, Anastomotic, Gu - Ureter	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Leak, Gu - Vagina	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Cystitis	14.2% 27/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	9.4% 17/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Urinary Color Change	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Urinary Retention	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Obstruction, Gu - Urethra	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Obstruction, Gu - Ureter	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Obstruction, Gu - Bladder	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Incontinence, Urinary	3.2% 6/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	2.2% 4/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Fistula, Gu - Vagina	1.1% 2/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Bladder Spasm	6.3% 12/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	4.4% 8/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Renal Failure	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Renal and urinary disorders Urinary Frequency	14.7% 28/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.2% 13/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Reproductive system and breast disorders Vaginal Dryness	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Reproductive system and breast disorders Sexual/Reproductive Function: Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Reproductive system and breast disorders Vaginal Discharge	15.8% 30/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	7.8% 14/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
General disorders Syndromes - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Vascular - Other	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Vein Injury - Extremity-Upper	0.53% 1/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.00% 0/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Thrombosis/Embolism (Vascular Access-Related)	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Thrombosis/Thrombus/Embolism	1.6% 3/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	1.1% 2/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.
Vascular disorders Phlebitis	0.00% 0/190 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.	0.56% 1/180 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Incidence of SAE among eligible and evaluable, treated patients.

Additional Information

Angela M. Kuras, Associate Director of Data Management

NRG Oncology Statistics and Data Management Center - Buffalo

Phone: 716-845-7733

Email: kurasa@nrgoncology.org

Results disclosure agreements

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

Restriction type: LTE60