Trial Outcomes & Findings for Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery (NCT NCT03694002)
NCT ID: NCT03694002
Last Updated: 2025-10-30
Results Overview
Compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab. Progression-free survival is defined as: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
up to 2 years after registration
Results posted on
2025-10-30
Participant Flow
21 participant enrolled, 20 of which were eligible. 3 participants withdrew consent before treatment start.
Participant milestones
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
13
|
|
Overall Study
COMPLETED
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Progression
|
4
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Other not protocol specified
|
1
|
0
|
|
Overall Study
Ineligible
|
0
|
1
|
|
Overall Study
Withdrew consent before starting treatment
|
0
|
3
|
Baseline Characteristics
Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 Participants
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=12 Participants
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 Years
n=5 Participants
|
65.7 Years
n=7 Participants
|
66.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hispanic
Yes
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Hispanic
No
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Hispanic
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Performance Status
0
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Performance Status
1
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pathologic cancer type
Thymic epithelial malignancy
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Pathologic cancer type
Thymic carcinoma, not otherwise specified
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Pathologic cancer type
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histologic subtype
Squamous cell
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Histologic subtype
Lymphoepithelioma like
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histologic subtype
Undifferentiated
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Palliative radiation therapy
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Palliative radiation therapy
No
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Neoadjuvant chemotherapy
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Neoadjuvant chemotherapy
No
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Adjuvant chemotherapy
Yes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Adjuvant chemotherapy
No
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 years after registrationPopulation: All eligible participants who received at least one cycle of treatment.
Compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab. Progression-free survival is defined as: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration
Outcome measures
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 Participants
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=12 Participants
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
8 Months
Interval 7.0 to 11.0
|
7 Months
Interval 6.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 2 years post randomizationPopulation: Participants who received any protocol treatment
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 Participants
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=9 Participants
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Frequency and Severity of Adverse Events
Dyspnea
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Ejection fraction decreased
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Fatigue
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Lymphocyte count decreased
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Neutrophil count decreased
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events
Anemia
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Diarrhea
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Resp, thoracic and mediastinal disorders - Other
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events
Thromboembolic event
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events
White blood cell decreased
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years after registrationPopulation: Participants who had measurable disease. 2 participants in the active comparator arm did not have measurable disease.
To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms in the subset of this patient population with measurable disease. Complete response - Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. Partial response - Applies only to patients with at least 1 measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all targets measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
Outcome measures
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 Participants
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=10 Participants
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Response Rate
Complete response
|
0 Participants
|
0 Participants
|
|
Response Rate
Partial repsonse
|
7 Participants
|
4 Participants
|
|
Response Rate
No response
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years after registrationPopulation: Participants with measurable disease and achieved a response. 2 participants in the active comparator arm had non-measurable disease. 6 participants in the active comparator arm had no response and 1 participants in the experimental arm had no response.
To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms in the subset of this patient population with measurable disease.
Outcome measures
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=7 Participants
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=4 Participants
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease Control Rate
|
2.92 months
Interval 1.4 to 3.23
|
1.67 months
Interval 1.47 to 6.43
|
SECONDARY outcome
Timeframe: Up to 2 years after registrationPopulation: Only one death has been reported - so this outcome can not be completed.
To compare overall survival between treatment arms. Overall survival is defined as time from date of registration to date of death due to any cause. Because of low accrual, and too few participant deaths, we do not plan to analyze or report with outcome.
Outcome measures
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 Participants
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=12 Participants
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
NA months
could not be calculated due to an insufficient number of events
|
NA months
could not be calculated due to an insufficient number of events
|
Adverse Events
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
Active Comparator: Arm B (Carboplatin, Paclitaxel)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 participants at risk
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=9 participants at risk
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Anal ulcer
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
Other adverse events
| Measure |
Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel)
n=8 participants at risk
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Active Comparator: Arm B (Carboplatin, Paclitaxel)
n=9 participants at risk
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Cardiac disorders
Cardiac disorders-Other
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Eye disorders
Blurred vision
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Eye disorders
Eye disorders-Other
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Eye disorders
Floaters
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
3/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Bloating
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Up to 2 years after randomization
|
33.3%
3/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Up to 2 years after randomization
|
44.4%
4/9 • Up to 2 years after randomization
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
General disorders
Chills
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
General disorders
Fatigue
|
87.5%
7/8 • Up to 2 years after randomization
|
44.4%
4/9 • Up to 2 years after randomization
|
|
General disorders
Fever
|
0.00%
0/8 • Up to 2 years after randomization
|
22.2%
2/9 • Up to 2 years after randomization
|
|
General disorders
General disorders and admin site conditions - Other
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
General disorders
Infusion related reaction
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
General disorders
Pain
|
37.5%
3/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Infections and infestations
Infections and infestations-Other
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Investigations
Ejection fraction decreased
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Up to 2 years after randomization
|
22.2%
2/9 • Up to 2 years after randomization
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Investigations
Weight loss
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Investigations
White blood cell decreased
|
37.5%
3/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Up to 2 years after randomization
|
22.2%
2/9 • Up to 2 years after randomization
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Up to 2 years after randomization
|
22.2%
2/9 • Up to 2 years after randomization
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Dizziness
|
37.5%
3/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Paresthesia
|
37.5%
3/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
37.5%
3/8 • Up to 2 years after randomization
|
44.4%
4/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Sinus pain
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Renal calculi
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Urinary tract pain
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Renal and urinary disorders
Urinary urgency
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
4/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
37.5%
3/8 • Up to 2 years after randomization
|
0.00%
0/9 • Up to 2 years after randomization
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.5%
3/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
3/8 • Up to 2 years after randomization
|
22.2%
2/9 • Up to 2 years after randomization
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
12.5%
1/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Up to 2 years after randomization
|
11.1%
1/9 • Up to 2 years after randomization
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Up to 2 years after randomization
|
22.2%
2/9 • Up to 2 years after randomization
|
Additional Information
Study Statistician
SWOG Statistics and Data Management Center
Phone: 2066672894
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60