Trial Outcomes & Findings for Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer (NCT NCT00101192)

Last Updated: 2014-03-17

Results Overview

Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

up to 6 months from study entry

Results posted on

2014-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Overall Study STARTED	76
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Overall Study Ineligible	6
Overall Study Inevaluable	1

Baseline Characteristics

Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab n=69 Participants Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Age, Continuous	50.8 years STANDARD_DEVIATION 11.2 • n=5 Participants
Age, Customized 20-29 years	1 participants n=5 Participants
Age, Customized 30-39 years	11 participants n=5 Participants
Age, Customized 40-49 years	18 participants n=5 Participants
Age, Customized 50-59 years	26 participants n=5 Participants
Age, Customized 60-69 years	9 participants n=5 Participants
Age, Customized 70-79 years	4 participants n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants
Cell Type Adenocarcinoma, Unspecified	21 participants n=5 Participants
Cell Type Clear Cell Carcinoma	1 participants n=5 Participants
Cell Type Mucinous Adenocarcinoma	1 participants n=5 Participants
Cell Type Adenosquamous	5 participants n=5 Participants
Cell Type Squamous Cell Carcinoma	41 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months from study entry

Population: Eligible and evaluable participants

Outcome measures

Outcome measures
Measure	Cetuximab n=69 Participants Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Tumor Response Complete Response	1 participants
Tumor Response Partial Response	7 participants
Tumor Response Increasing Disease	17 participants
Tumor Response Stable Disease	34 participants
Tumor Response Indeterminate	10 participants

SECONDARY outcome

Timeframe: up to 5 years from study entry

Outcome measures

Outcome data not reported

Adverse Events

Cetuximab

Serious events: 33 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab n=69 participants at risk Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
General disorders Death No Ctcae Term - Disease Progression Nos	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Fistula, Gi - Ileum	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Obstruction, Gi - Colon	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Perforation, Gi - Small Bowel Nos	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Vomiting	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Nausea	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Diarrhea	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gu - Vagina	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage/Bleeding - Other	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Creatinine	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Ggt	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypomagnesemia	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain - Other	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Extremity-Limb	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Muscle	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Obstruction, Gu - Urethra	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Obstruction, Gu - Ureter	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Fistula, Gu - Vagina	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Renal Failure	4.3% 3/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Thrombosis/Thrombus/Embolism	7.2% 5/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.

Other adverse events

Other adverse events
Measure	Cetuximab n=69 participants at risk Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Renal and urinary disorders Renal Failure	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Urinary Frequency	10.1% 7/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Reproductive system and breast disorders Vaginal Discharge	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Flu-Like Syndrome	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Thrombosis/Thrombus/Embolism	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Phlebitis	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Immune system disorders Allergic Reaction/Hypersensitivity	13.0% 9/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Ear and labyrinth disorders Otitis Middle Ear	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Ear and labyrinth disorders Tinnitus	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Ear and labyrinth disorders Hearing (Monitoring Program)	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Neutrophils	18.8% 13/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Platelets	18.8% 13/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Leukocytes	33.3% 23/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Hemolysis	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Hemoglobin	72.5% 50/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders Palpitations	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders S/N Arrhythmia: Sinus Tachycardia	4.3% 3/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders S/N Arrhythmia: Atrial Tachycardia	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders Hypertension	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders Hypotension	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Cardiac disorders Cardipulmonary Arrest	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Inr	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Fibrinogen	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Ptt	4.3% 3/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Sweating	7.2% 5/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Fever	14.5% 10/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Weight Loss	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Rigors/Chills	7.2% 5/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Fatigue	76.8% 53/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Insomnia	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Nail Changes	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	20.3% 14/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Wound Complication, Non-Infectious	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Acne	36.2% 25/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Rash	55.1% 38/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Dry Skin	15.9% 11/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Decubitus	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Pruritus	10.1% 7/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Burn	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Flushing	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Hand-Foot	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Endocrine disorders Hot Flashes	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Endocrine disorders Masculinization Of Female	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Fistula, Gi - Rectum	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Gastritis	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Heartburn	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dental: Teeth	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Ileus	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dysphagia	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Distention	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Taste Alteration	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dry Mouth	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	17.4% 12/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Stricture, Gi - Colon	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Vomiting	42.0% 29/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Anorexia	50.7% 35/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dehydration	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Constipation	59.4% 41/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Nausea	63.8% 44/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Gastrointestinal - Other	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Gastrointestinal disorders Diarrhea	29.0% 20/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gu - Urinary Nos	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gu - Vagina	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gi - Rectum	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gu - Ovary	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage/Pulmonary - Nose	7.2% 5/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gi - Oral Cavity	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gu - Bladder	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage, Gi - Abdomen Nos	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Vascular disorders Petechiae	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Uterus	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf Unknown Anc: Lung (Pneumonia)	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf Unknown Anc: Nose	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	15.9% 11/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Infection - Other	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf Unknown Anc: Urinary Tract Nos	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	11.6% 8/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Edema: Limb	20.3% 14/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Ast	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Cholesterol,serum High	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Proteinuria	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Creatinine	21.7% 15/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	31.9% 22/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Ggt	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Alt	14.5% 10/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Alkaline Phosphatase	27.5% 19/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Bilirubin	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypermagnesemia	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypophosphatemia	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyponatremia	29.0% 20/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Cpk	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Bicarbonate, Serum-Low	4.3% 3/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Amylase	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypernatremia	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypocalcemia	34.8% 24/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyperkalemia	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyperglycemia	34.8% 24/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypokalemia	31.9% 22/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypoglycemia	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypercalcemia	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypomagnesemia	39.1% 27/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Myositis	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Fracture	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Extremity-Upper (Function)	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Gait/Walking	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Arthritis	7.2% 5/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness - Left-Sided	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	7.2% 5/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Pyramidal Tract Dysfunction	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Mood Alteration - Depression	33.3% 23/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Mood Alteration - Anxiety	15.9% 11/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Tremor	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Confusion	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Dizziness	13.0% 9/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Neuropathy,cranial - Cn Xii Motor-Tongue	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Neuropathy,cranial - Cn Ix Motor-Pharynx	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Neuropathy-Sensory	36.2% 25/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Nervous system disorders Neuropathy-Motor	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Eye disorders Dry Eye	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Eye disorders Flashing Lights/Floaters	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Eye disorders Blurred Vision	21.7% 15/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain - Other	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Pelvis	8.7% 6/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Breast	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Vagina	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Chest /Thorax Nos	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Chest Wall	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Throat/Pharynx/Larynx	4.3% 3/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Head/Headache	21.7% 15/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Neck	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Extremity-Limb	21.7% 15/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Buttock	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Back	29.0% 20/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Joint	10.1% 7/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Bone	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Kidney	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Bladder	4.3% 3/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Stomach	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Rectum	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Oral Cavity	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Esophagus	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Dental/Teeth/Peridontal	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Abdominal Pain Nos	33.3% 23/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Skin	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Tumor	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Muscle	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
General disorders Pain: Neuralgia	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Airway Obstruction - Bronchus	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Nasal/Paranasal Reactions	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Voice Changes	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Cough	21.7% 15/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	30.4% 21/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Renal/Genitourinary - Other	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Leak, Gu - Vagina	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Cystitis	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Urinary Retention	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Obstruction, Gu - Ureter	5.8% 4/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Incontinence, Urinary	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Fistula, Gu - Vagina	1.4% 1/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Fistula, Gu - Bladder	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Renal and urinary disorders Bladder Spasm	2.9% 2/69 • from study entry up to 5 years All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.

Additional Information

Melissa Leventhal

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-341-3408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place