Trial Outcomes & Findings for Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT01642082)
NCT ID: NCT01642082
Last Updated: 2018-03-13
Results Overview
Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be \< 10 mm in short axis; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.
Results posted on
2018-03-13
Participant Flow
All patients underwent disease evaluation with baseline CT of the chest, abdomen and pelvis. After obtaining informed consent and verification of eligibility, patients were enrolled and treatment initiated.
Participant milestones
| Measure |
Dalantercept
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Dalantercept)
n=28 Participants
Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Dalantercept: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Customized
40-49
|
1 participants
n=5 Participants
|
|
Age, Customized
50-59
|
9 participants
n=5 Participants
|
|
Age, Customized
60-69
|
13 participants
n=5 Participants
|
|
Age, Customized
70-79
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.Population: All eligible and treated patients
Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be \< 10 mm in short axis; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Outcome measures
| Measure |
Dalantercept
n=28 Participants
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v4.0)
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 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
|
|---|---|---|---|---|---|---|
|
Response
|
0 percentage of participants
Interval 0.0 to 10.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive diseasePopulation: All eligible and treated patients
Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions. Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months.
Outcome measures
| Measure |
Dalantercept
n=28 Participants
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v4.0)
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 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
|
|---|---|---|---|---|---|---|
|
Treatment and Progression-free Survival at 6 Months
|
10.7 percentage of participants
Interval 3.0 to 25.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: : CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.Population: All eligible and treated patients
Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months.
Outcome measures
| Measure |
Dalantercept
n=28 Participants
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v4.0)
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 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 at 6 Months
|
17.9 percentage of participants
Interval 7.3 to 33.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.Population: All eligible and treated patients.
Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Dalantercept
n=28 Participants
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v4.0)
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 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
|
|---|---|---|---|---|---|---|
|
Duration of Progression-free Survival
|
2.1 months
Interval 1.4 to 3.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients are followed every three months for the first two years and then every six months for the next three years.Population: All eligible and treated patients
Duration of survival is defined as the duration alive from study entry until death or last contact.
Outcome measures
| Measure |
Dalantercept
n=28 Participants
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v4.0)
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 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
|
|---|---|---|---|---|---|---|
|
Duration of Survival
|
14.5 months
Interval 7.0 to 17.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every cycle of study treatment and after treatment for a maximum of 5 years from study entryPopulation: Eligible and treated patients
The frequencies of the maximum grade of any acute adverse event, regardless of attribution are reported during treatment and up to 30 days after stopping the study treatment are reported.
Outcome measures
| Measure |
Dalantercept
n=28 Participants
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v4.0)
n=28 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v4.0)
n=28 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
n=28 Participants
Number of patients who experienced a grade 3 event using Common Terminology version 4.0
|
Grade 4 (CTCAE v 4.0)
n=28 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
n=28 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Adverse Events (Primary Serious and All Other AEs)
Hypoalbuminemia
|
19 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Anemia
|
13 Participants
|
5 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Abdominal Distention
|
24 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Abdominal Pain
|
20 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Ascites
|
24 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Constipation
|
11 Participants
|
12 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Diarrhea
|
22 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Gastric Hemorrhage
|
27 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Nausea
|
16 Participants
|
11 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Rectal Fistula
|
27 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Rectal Hemorrhage
|
26 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Vomiting
|
19 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Edema Face
|
26 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Edema Limbs
|
11 Participants
|
15 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Fatigue
|
4 Participants
|
17 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Prolonged activated partial thromboplastin time
|
27 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Alkaline Phosphatase Increased
|
22 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Creatinine Increased
|
19 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Lymphocyte Count Decreased
|
25 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Weight Loss
|
24 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Anorexia
|
24 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Dehydration
|
26 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Hyperglycemia
|
22 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Hypoglycemia
|
27 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Hypokalemia
|
24 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Arthralgia
|
24 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Back Pain
|
19 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Myalgia
|
25 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Dizziness
|
26 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Headache
|
15 Participants
|
13 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Neuralgia
|
27 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Urinary Tract Obstruction
|
27 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Dyspnea
|
18 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Epistaxis
|
24 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Pleural Effusion
|
24 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Hypertension
|
25 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (Primary Serious and All Other AEs)
Thromboembolic Event
|
26 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dalantercept
Serious events: 11 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalantercept
n=28 participants at risk
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Rectal Fistula
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Ascites
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
2/28 • Number of events 2 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Vascular disorders
Thromboembolic Event
|
3.6%
1/28 • Number of events 1 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
Other adverse events
| Measure |
Dalantercept
n=28 participants at risk
Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
53.6%
15/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Cardiac disorders
Ventricular Arrhythmia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Ear and labyrinth disorders
Hearing Impaired
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Ear and labyrinth disorders
Ear Pain
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Eye disorders
Flashing Lights
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Eye disorders
Eye Pain
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Eye disorders
Blurred Vision
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Eye disorders
Floaters
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Constipation
|
60.7%
17/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
6/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
9/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
8/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Mucositis Oral
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Abdominal Distension
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Nausea
|
42.9%
12/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Gastroparesis
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Gastrointestinal disorders
Ascites
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Pain
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Localized Edema
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Injection Site Reaction
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Edema Trunk
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Non-Cardiac Chest Pain
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Edema Limbs
|
60.7%
17/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Edema Face
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Fatigue
|
85.7%
24/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
General disorders
Fever
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Infections and infestations
Wound Infection
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Infections and infestations
Upper Respiratory Infection
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Infections and infestations
Soft Tissue Infection
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Infections and infestations
Papulopustular Rash
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Weight Loss
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Weight Gain
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Lymphocyte Count Decreased
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Creatinine Increased
|
32.1%
9/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Aspartate Aminotransferase Increased
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Alkaline Phosphatase Increased
|
21.4%
6/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Alanine Aminotransferase Increased
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
6/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.1%
9/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.4%
6/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
28.6%
8/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
17.9%
5/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Paresthesia
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Neuralgia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Headache
|
46.4%
13/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Facial Nerve Disorder
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Nervous system disorders
Dizziness
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Psychiatric disorders
Depression
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Psychiatric disorders
Anxiety
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Renal and urinary disorders
Urinary Tract Pain
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Renal and urinary disorders
Urinary Frequency
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
4/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
8/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
7/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
7.1%
2/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
21.4%
6/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Vascular disorders
Thromboembolic Event
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
|
Vascular disorders
Hypertension
|
10.7%
3/28 • Every cycle of study treatment and after treatment for a maximum of 5 years from study entry
The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported
|
Additional Information
Linda Gedeon, BA, CCRP Clinical Research Coordinator
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place