Trial Outcomes & Findings for Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy (NCT NCT01220609)
NCT ID: NCT01220609
Last Updated: 2019-08-08
Results Overview
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. 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
26 participants
Primary outcome timeframe
Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.
Results posted on
2019-08-08
Participant Flow
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
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
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-Wrong primary cancer site
|
1
|
|
Overall Study
Ineligible- Wrong cell type
|
1
|
|
Overall Study
Ineligible-Never treated
|
1
|
Baseline Characteristics
Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy
Baseline characteristics by cohort
| Measure |
Ixabepilone
n=23 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
|
55.5 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Age, Customized
40-49 years
|
5 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
12 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Histologic Type
Leiomyosarcoma
|
22 participants
n=5 Participants
|
|
Histologic Type
Carcinosarcoma, malignant mixed Mullerian tumor
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.Population: Eligible and treated patients
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. 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=23 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
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Tumor Response
|
0 percentage of participants
Interval 0.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every cycle until completion of study treatment up to 30 days after stopping study treatmentPopulation: Eligible and evaluable patients.
Outcome measures
| Measure |
Ixabepilone
n=23 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
|
Grade 1 (CTCAE v 4.0)
n=23 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
n=23 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
n=23 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
n=23 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
n=23 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Dizziness
|
20 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Thrombocytopenia
|
17 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Neutropenia
|
8 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Platelet count decreased
|
17 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Nausea
|
16 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Vomiting
|
19 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Mucositis
|
20 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Diarrhea
|
18 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Fatigue
|
10 Participants
|
10 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Anorexia
|
19 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Musculoskeletal/Connective tissue
|
19 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Dyspnea
|
19 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Leukopenia
|
5 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Anemia
|
2 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Constipation
|
15 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Myalgia
|
20 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Perpheral sensory neuropathy
|
17 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Alopecia
|
13 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 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-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Outcome measures
| Measure |
Ixabepilone
n=23 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
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
1.4 months
Interval 1.2 to 1.6
|
—
|
—
|
—
|
—
|
—
|
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=23 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
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
7.6 months
Interval 4.5 to 13.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Ixabepilone
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone
n=23 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
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Colonic Perforation
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Neutrophil Count Decreased
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Other adverse events
| Measure |
Ixabepilone
n=23 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
|
91.3%
21/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Sinus Tachycardia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
External Ear Inflammation
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Blurred Vision
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
39.1%
9/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
21.7%
5/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Bloating
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis Oral
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Ileus
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Oral Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
30.4%
7/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Non-Cardiac Chest Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Edema Limbs
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fatigue
|
56.5%
13/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fever
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Infusion Related Reaction
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Allergic Reaction
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Weight Loss
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Weight Gain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Platelet Count Decreased
|
26.1%
6/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Neutrophil Count Decreased
|
65.2%
15/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Blood Bilirubin Increased
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
White Blood Cell Decreased
|
78.3%
18/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Aspartate Aminotransferase Increased
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Alkaline Phosphatase Increased
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
26.1%
6/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder -
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
30.4%
7/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Paresthesia
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Movements Involuntary
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dysgeusia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Frequency
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Hematuria
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Bladder Spasm
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.1%
6/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.5%
10/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Thromboembolic Event
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Lymphedema
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
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