Trial Outcomes & Findings for Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT00095979)
NCT ID: NCT00095979
Last Updated: 2019-07-24
Results Overview
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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 non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Results posted on
2019-07-24
Participant Flow
The study was activated on 5/2/2005 and closed to accrual on 1/3/2008 (suspended from 4/3/2006 to 4/1/2007).
Participant milestones
| Measure |
Ixabepilone
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ixabepilone
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Overall Study
Ineligible: Second primary cancer site
|
2
|
Baseline Characteristics
Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone
n=50 Participants
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Age, Customized
20-29 years
|
0 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
0 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
2 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
11 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
19 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
16 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent
|
50 participants
n=5 Participants
|
|
Histologic Type
Adenocarcinoma, Unspecified
|
1 participants
n=5 Participants
|
|
Histologic Type
Clear Cell Carcinoma
|
1 participants
n=5 Participants
|
|
Histologic Type
Endometrioid Adenocarcinoma
|
22 participants
n=5 Participants
|
|
Histologic Type
Mixed Epithelial Carcinoma
|
4 participants
n=5 Participants
|
|
Histologic Type
Serous Adenocarcinoma
|
21 participants
n=5 Participants
|
|
Histologic Type
Carcinosarcoma-homologous
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive diseasePopulation: Eligible and Treated Patients
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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 non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
Ixabepilone
n=50 Participants
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
Grade 2
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 3
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 4
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 5
Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
|---|---|---|---|---|---|
|
Tumor Response
|
12 percentage of participants
Interval 7.0 to 100.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)Population: Eligible and treated patients
Outcome measures
| Measure |
Ixabepilone
n=50 Participants
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
Grade 2
n=50 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 3
n=50 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 4
n=50 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 5
n=50 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
|---|---|---|---|---|---|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Alopecia
|
7 Participants
|
23 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Leukopenia
|
9 Participants
|
14 Participants
|
17 Participants
|
7 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Neutropenia
|
5 Participants
|
7 Participants
|
14 Participants
|
12 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Anemia
|
12 Participants
|
29 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Thrombocytopenia
|
13 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Allergy/Immunology
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Auditory/ear
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Cardiac
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Coagulation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Constitutional
|
15 Participants
|
14 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Dermatologic
|
7 Participants
|
21 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Gastrointestinal
|
11 Participants
|
15 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Genitourinary
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Hemorrhage
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Infection
|
0 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Lymphatics
|
8 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Metabolic
|
9 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Musculoskeletal
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Neurosensory
|
19 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Other neurologic
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Ocular/visual
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Pain
|
9 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Pulmonary
|
10 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Vascular
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.Population: Eligible and Treated Patients
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Ixabepilone
n=50 Participants
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
Grade 2
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 3
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 4
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 5
Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
3.1 months
Interval 2.8 to 4.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years of follow-up.Population: Eligible and treated patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Ixabepilone
n=50 Participants
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
Grade 2
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 3
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 4
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
Grade 5
Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
|
|---|---|---|---|---|---|
|
Overall Survival
|
8.8 months
Interval 6.3 to 11.9
|
—
|
—
|
—
|
—
|
Adverse Events
Ixabepilone
Serious events: 25 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone
n=50 participants at risk
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Fatigue
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Anorexia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Febrile Neutropenia
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Creatinine
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Syncope
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Mood Alteration - Depression
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Memory Impairment
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Abdominal Pain Nos
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Tumor
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
Other adverse events
| Measure |
Ixabepilone
n=50 participants at risk
Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Neutrophils
|
72.0%
36/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Platelets
|
40.0%
20/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Leukocytes
|
94.0%
47/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
96.0%
48/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Immune system disorders
Rhinitis
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Cardiac disorders
Ventricular Arrhythmia - Pvcs
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Cardiac disorders
Hypertension
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Cardiac disorders
Hypotension
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Inr
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Sweating
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Patient Odor
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Fever
|
10.0%
5/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Weight Loss
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Rigors/Chills
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Fatigue
|
80.0%
40/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Insomnia
|
14.0%
7/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
12.0%
6/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
60.0%
30/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
8/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Endocrine disorders
Hot Flashes
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Endocrine disorders
Diabetes
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Endocrine disorders
Hypoparathyroidism
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Heartburn
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Leak, Gi - Rectum
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Taste Alteration
|
12.0%
6/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
12.0%
6/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Esophagus
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Vomiting
|
38.0%
19/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
25/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Dehydration
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Constipation
|
48.0%
24/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Nausea
|
44.0%
22/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Gastrointestinal disorders
Diarrhea
|
44.0%
22/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Middle Ear
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Febrile Neutropenia
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Infection - Other
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
14.0%
7/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf Unknown Anc: Lip/Perioral
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
24.0%
12/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Ast
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Gfr
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Proteinuria
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Creatinine
|
20.0%
10/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
10/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Alt
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Bilirubin
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.0%
13/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.0%
9/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.0%
14/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.0%
12/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.0%
15/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Left-Sided
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Mood Alteration - Depression
|
10.0%
5/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Ataxia
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Confusion
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Memory Impairment
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Dizziness
|
12.0%
6/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Neuropathy-Sensory
|
64.0%
32/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Nervous system disorders
Neuropathy-Motor
|
10.0%
5/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Ocular/Visual - Other
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Uveitis
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Watery Eye
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Dry Eye
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Flashing Lights/Floaters
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Blurred Vision
|
10.0%
5/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Eye disorders
Eyelid Dysfunction
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Pelvis
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Breast
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Vagina
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Chest /Thorax Nos
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Chest Wall
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Eye
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Head/Headache
|
14.0%
7/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Extremity-Limb
|
22.0%
11/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Back
|
16.0%
8/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Joint
|
12.0%
6/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Bone
|
6.0%
3/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Kidney
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Bladder
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Pain Nos
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Stomach
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Oral Cavity
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Abdominal Pain Nos
|
28.0%
14/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Middle Ear
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Tumor
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Muscle
|
16.0%
8/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
General disorders
Pain: Neuralgia
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
11/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.0%
17/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Leak, Gu - Vagina
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Cystitis
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Urinary Retention
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
8.0%
4/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Bladder Spasm
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Renal and urinary disorders
Urinary Frequency
|
4.0%
2/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.0%
1/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
10.0%
5/50 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60