Trial Outcomes & Findings for Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer (NCT NCT01168232)
NCT ID: NCT01168232
Last Updated: 2019-08-08
Results Overview
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Every other cycle for first 6 months; then every 3 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.1 cycle is 21 days
Results posted on
2019-08-08
Participant Flow
The study was activated on 9/7/2010 and closed to accrual on 8/26/2013 (suspended from 3/5/2012 to 9/30/2012).
Participant milestones
| Measure |
Ixabepilone
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Ixabepilone
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Overall Study
Ineligible-Second primary cancer site
|
1
|
|
Overall Study
Ineligible- Wrong cell type
|
6
|
|
Overall Study
Ineligible-Inadequate pathology
|
1
|
Baseline Characteristics
Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone
n=34 Participants
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 7.7 • 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
|
0 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
13 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent
|
34 participants
n=5 Participants
|
|
Histologic Type
Carcinosarcoma-heterologus
|
17 participants
n=5 Participants
|
|
Histologic Type
Carcinosarcoma-homologous
|
11 participants
n=5 Participants
|
|
Histologic Type
Carcinosarcoma, MMT
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for first 6 months; then every 3 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.1 cycle is 21 daysPopulation: Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
Outcome measures
| Measure |
Ixabepilone
n=34 Participants
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Objective Tumor Response
|
11.8 percentage
Interval 4.2 to 100.0
|
PRIMARY outcome
Timeframe: During treatment and up to 30 days after stopping the study treatmentPopulation: Eligible and Treated Participants
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
Outcome measures
| Measure |
Ixabepilone
n=34 Participants
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Other nervous system disorders
|
2 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Respitory, thoracic and mediastinal disorders
|
5 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Leukopenia
|
15 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Thrombocytopenia
|
0 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Neutropenia
|
16 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Anemia
|
5 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Other Investigations
|
4 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Other Blood/lymphatics
|
2 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Cardiac Disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Gastrointestinal disorders
|
6 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
General disorders and administration site conditio
|
9 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Infections and infestations
|
3 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Metabolism and nutrition disorders
|
12 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Musculoskelatal and connective tissue disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Neoplasms benign, malignant and unspecified
|
2 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Peripheral sensory neuropathy
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period.
Vascular disorders
|
8 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-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1
Outcome measures
| Measure |
Ixabepilone
n=34 Participants
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Progression-free Survival
|
1.7 months
Interval 1.3 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=34 Participants
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Overall Survival
|
7.7 months
Interval 4.0 to 11.7
|
Adverse Events
Ixabepilone
Serious events: 17 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone
n=34 participants at risk
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Death Nos
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Infections and infestations
Soft Tissue Infection
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Lymphocyte Count Decreased
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Neutrophil Count Decreased
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Vascular disorders
Thromboembolic Event
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
Other adverse events
| Measure |
Ixabepilone
n=34 participants at risk
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
97.1%
33/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Cardiac disorders
Sinus Bradycardia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Eye disorders
Blurred Vision
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Constipation
|
44.1%
15/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Diarrhea
|
35.3%
12/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
12/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Bloating
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Rectal Mucositis
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.5%
9/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Mucositis Oral
|
17.6%
6/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Oral Pain
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Abdominal Distension
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Nausea
|
58.8%
20/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Ascites
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Pain
|
17.6%
6/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Neck Edema
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Malaise
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Localized Edema
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Edema Limbs
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Edema Face
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Fatigue
|
70.6%
24/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Fever
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Chills
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
General disorders
Infusion Related Reaction
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Immune system disorders
Allergic Reaction
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Infections and infestations
Skin Infection
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Infections and infestations
Nail Infection
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Infections and infestations
Urinary Tract Infection
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Weight Loss
|
17.6%
6/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Weight Gain
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Platelet Count Decreased
|
44.1%
15/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Lymphocyte Count Decreased
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Inr Increased
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Fibrinogen Decreased
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Creatinine Increased
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Neutrophil Count Decreased
|
82.4%
28/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
White Blood Cell Decreased
|
85.3%
29/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Aspartate Aminotransferase Increased
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Alkaline Phosphatase Increased
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Investigations
Alanine Aminotransferase Increased
|
14.7%
5/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.4%
11/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.7%
5/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.7%
5/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.4%
11/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.4%
10/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.7%
5/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.3%
12/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
14.7%
5/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.4%
10/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Tremor
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
55.9%
19/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Paresthesia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Headache
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Dizziness
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Concentration Impairment
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Nervous system disorders
Cognitive Disturbance
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Psychiatric disorders
Depression
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Renal and urinary disorders
Urinary Retention
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Renal and urinary disorders
Urinary Frequency
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Renal and urinary disorders
Hematuria
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.2%
14/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
4/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.9%
1/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.9%
18/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Vascular disorders
Thromboembolic Event
|
5.9%
2/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
|
Vascular disorders
Hypertension
|
20.6%
7/34 • All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo Office
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60