Trial Outcomes & Findings for Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus (NCT NCT00379145)
NCT ID: NCT00379145
Last Updated: 2017-12-12
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
20 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
Results posted on
2017-12-12
Participant Flow
This trial was opened to patient entry on June 4, 2007 and was closed to accrual on November 3, 2008.
Participant milestones
| Measure |
Trabectidin
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Baseline characteristics by cohort
| Measure |
Trabectidin
n=20 Participants
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
<40 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
>79 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.Population: 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 |
Trabectidin
n=20 Participants
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
|---|---|---|---|---|---|
|
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Partial response
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Complete response
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-upPopulation: Eligible and treated patients
Outcome measures
| Measure |
Trabectidin
n=20 Participants
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=20 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 2 (CTCAE v 3.0)
n=20 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 3 (CTCAE v 3.0)
n=20 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 4 (CTCAE v 3.0)
n=20 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
|---|---|---|---|---|---|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Thrombocytopenia
|
13 participants
|
4 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Leukopenia
|
2 participants
|
0 participants
|
7 participants
|
10 participants
|
1 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Neutropenia
|
2 participants
|
0 participants
|
2 participants
|
11 participants
|
5 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Anemia
|
3 participants
|
10 participants
|
6 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Other hematologic
|
18 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Coagulation
|
19 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hemorrhage
|
18 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Nausea
|
3 participants
|
11 participants
|
6 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Vomiting
|
7 participants
|
10 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Bilirubin
|
19 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
ALT
|
9 participants
|
4 participants
|
5 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Alkaline Phosphatase
|
19 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Dermatologic
|
14 participants
|
4 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Infection
|
17 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pulmonary
|
15 participants
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Metabolic
|
8 participants
|
5 participants
|
4 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Lymphatics
|
16 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pain
|
8 participants
|
10 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Constitutional
|
17 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Fatigue
|
5 participants
|
8 participants
|
7 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Musculoskeletal
|
15 participants
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Neurotoxicity
|
16 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Peripheral neuropathy
|
18 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Renal
|
19 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Ocular
|
16 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Vascular
|
19 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Flu-like syndrome
|
19 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Trabectidin
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabectidin
n=20 participants at risk
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Other adverse events
| Measure |
Trabectidin
n=20 participants at risk
Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Immune system disorders
Rhinitis
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Neutrophils
|
90.0%
18/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Platelets
|
40.0%
8/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Leukocytes
|
90.0%
18/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Hemoglobin
|
85.0%
17/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Hypertension
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardiac General - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Inr
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Ptt
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Gain
|
20.0%
4/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fever
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Loss
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Rigors/Chills
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fatigue
|
80.0%
16/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Bruising
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Flushing
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Endocrine disorders
Hot Flashes
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Distention
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Taste Alteration
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
65.0%
13/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Anorexia
|
30.0%
6/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Constipation
|
70.0%
14/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Nausea
|
85.0%
17/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
8/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Febrile Neutropenia
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
25.0%
5/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Ast
|
50.0%
10/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Proteinuria
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alt
|
60.0%
12/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Cpk
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
6/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neurology - Other
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Depression
|
20.0%
4/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Agitation
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Sensory
|
25.0%
5/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Motor
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Ocular/Visual - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Flashing Lights/Floaters
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Blurred Vision
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Pelvis
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Chest /Thorax Nos
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Chest Wall
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Head/Headache
|
45.0%
9/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Neck
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Extremity-Limb
|
30.0%
6/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Back
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Joint
|
25.0%
5/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Stomach
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Oral Cavity
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Abdominal Pain Nos
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Liver
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Muscle
|
15.0%
3/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.0%
7/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Frequency
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Flu-Like Syndrome
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Vascular - Other
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
10.0%
2/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.0%
1/20 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60