Trial Outcomes & Findings for Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor (NCT NCT00068419)
NCT ID: NCT00068419
Last Updated: 2020-02-19
Results Overview
Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2020-02-19
Participant Flow
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
24
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Ineligible
|
11
|
Baseline Characteristics
Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
n=70 Participants
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Age, Categorical
<=18 years
|
62 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All eligible patients.
Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
n=59 Participants
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Percentage of Patients Failure Free at 2 Years Following Study Entry
|
36 percentage of participants
Interval 23.0 to 48.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All eligible patients
The percentage of patients experiencing a grade 3 or higher adverse event as assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
n=59 Participants
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.
|
3.4 Percentage of participants
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: All eligible patients
Percentage of patients with a tumor response where tumor response is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
n=59 Participants
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Percentage of Patients With Tumor Response From Imaging
|
8.0 Percentage of participants
Interval 1.1 to 14.9
|
SECONDARY outcome
Timeframe: From baseline to up to 5 yearsPopulation: Outcome not reported because the required data were not recorded.
The mean change in response measured by MRI. Response is assessed by the lesion size which is derived from the sum of the longest of the three orthogonal diameters (from MRI) of each target lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to up to 2 yearsPopulation: Data not available for analysis due to no data were collected
The failure free survival is compared by the log-rank test between patient subgroups defined by pathological response of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At study entryPopulation: Data not available for analysis due to no data were collected.
The percentage of patients experiencing short-term endocrine toxicity between treatment groups is compared using the chi-square test
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
n=59 participants at risk
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Psychiatric disorders
Depression
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
n=59 participants at risk
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.9%
20/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Acidosis
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
8/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Alkaline phosphatase increased
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Blood and lymphatic system disorders
Anemia
|
10.2%
6/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Aspartate aminotransferase increased
|
11.9%
7/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Nervous system disorders
Ataxia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Blood gonadotrophin abnormal
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Infections and infestations
Catheter related infection
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Infections and infestations
Conjunctivitis infective
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Constipation
|
13.6%
8/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Creatinine increased
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Psychiatric disorders
Depression
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
5/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Nervous system disorders
Dizziness
|
8.5%
5/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Nervous system disorders
Dysgeusia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
General disorders
Edema limbs
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
11.9%
7/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Endocrine disorders
Endocrine disorders - Other
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Esophagitis
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Eye disorders
Eye disorders - Other
|
8.5%
5/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
General disorders
Fatigue
|
13.6%
8/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
General disorders
Fever
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Vascular disorders
Flushing
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
General disorders
Gait disturbance
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
GGT increased
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Reproductive system and breast disorders
Gynecomastia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Nervous system disorders
Headache
|
20.3%
12/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Vascular disorders
Hot flashes
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.6%
8/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Vascular disorders
Hypertension
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.8%
4/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.3%
9/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Investigations - Other
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Reproductive system and breast disorders
Irregular menstruation
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Lymphocyte count decreased
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Nausea
|
13.6%
8/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Neutrophil count decreased
|
6.8%
4/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Metabolism and nutrition disorders
Obesity
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
General disorders
Pain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
5/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Serum amylase increased
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Stomach pain
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Renal and urinary disorders
Urinary tract pain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Renal and urinary disorders
Urine discoloration
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Vascular disorders
Vascular disorders - Other
|
3.4%
2/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
16/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
Weight gain
|
1.7%
1/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
|
Investigations
White blood cell decreased
|
5.1%
3/59 • Duration of protocol therapy plus 30 days.
Reporting is for all patients who received protocol therapy (11 patients were ineligible for protocol therapy).
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER