Trial Outcomes & Findings for Study of Oral Dasatinib in Subjects With Myelodysplastic Syndrome (MDS) and Excess Marrow Blasts (NCT NCT00624585)
NCT ID: NCT00624585
Last Updated: 2013-12-16
Results Overview
Complete remission (modified IWG); IWG = International MDS Working Group. Bone Marrow Response must last ≥4 weeks. Bone marrow evaluation: Bone marrow showing ≤5% myeloblasts with normal maturation of all cell lines.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
1 Year 4 Months
Results posted on
2013-12-16
Participant Flow
Patients with Int-2 or High risk MDS according to International Prognostic Scoring System (IPSS) score. All World Health Organization (WHO) subtypes of Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Myelodysplastic / Myeloproliferative (MDS/MPD) were allowed.
Acute Myeloid Leukemia Multilineage Dysplasia (MDS/AML) with \<30% blasts (RAEB-t) who either declined or were deemed unfit for induction chemotherapy were also eligible. Exclusion criteria were WBC \>50,000 off hydroxyurea, another malignancy requiring radiation or chemotherapy within the past 3 years, or concurrent therapy for MDS or AML.
Participant milestones
| Measure |
Dasatinib Dose Escalation
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Dasatinib Dose Escalation
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Disease Progression
|
6
|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Study of Oral Dasatinib in Subjects With Myelodysplastic Syndrome (MDS) and Excess Marrow Blasts
Baseline characteristics by cohort
| Measure |
Dasatinib Dose Escalation
n=18 Participants
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Age, Continuous
|
73.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 Year 4 MonthsPopulation: All Participants
Complete remission (modified IWG); IWG = International MDS Working Group. Bone Marrow Response must last ≥4 weeks. Bone marrow evaluation: Bone marrow showing ≤5% myeloblasts with normal maturation of all cell lines.
Outcome measures
| Measure |
Dasatinib Dose Escalation
n=18 Participants
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Number of Participants With Marrow Complete Remission (CR)
|
3 participants
|
SECONDARY outcome
Timeframe: 1 Year 4 MonthsPopulation: All Participants
Hematologic improvement in platelets, red blood cell (RBC), neutrophils according to modified IWG Criteria; Cytogenetic response (modified IWG); Change in percentage of blasts in bone marrow and peripheral blood; Src-Tyr416 phosphorylation in medullary myeloblasts. Hematologic improvements must last ≥ 8 weeks.
Outcome measures
| Measure |
Dasatinib Dose Escalation
n=18 Participants
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Number of Participants With Hematologic Improvement
|
0 participants
|
SECONDARY outcome
Timeframe: 1 Year 4 MonthsPopulation: All Participants
Partial remission (PR) (modified IWG); IWG = International MDS Working Group. All of the CR criteria (if abnormal prior to treatment), except: Bone marrow evaluation: Blasts decreased by ≥ 50% over pretreatment but still \>5%. Cellularity and morphology are not relevant.
Outcome measures
| Measure |
Dasatinib Dose Escalation
n=18 Participants
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Number of Participants With Partial Remission (PR)
|
0 participants
|
SECONDARY outcome
Timeframe: 1 Year 4 MonthsPopulation: All Participants
Outcome measures
| Measure |
Dasatinib Dose Escalation
n=18 Participants
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Number of Participants With Stable Disease (SD)
|
10 participants
|
Adverse Events
Dasatinib Dose Escalation
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib Dose Escalation
n=18 participants at risk
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Gastrointestinal disorders
Anorexia - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Grade 4
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Cardiac disorders
Cardiac general - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Hepatobiliary disorders
Cholecystitis - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Nervous system disorders
Confusion - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Dehydration - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Diarrhea - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 2
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 2 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3 - **Definitely related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Edema: limb - Grade 2
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Fatigue - Grade 3 - *Possibly related
|
16.7%
3/18 • Number of events 4 • 1 Year 4 Months
|
|
Infections and infestations
Febrile neutropenia - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Febrile neutropenia - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Fever in absence of neutropenia - Grade 2
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Metabolism and nutrition disorders
Glucose, serum - low - Grade 4
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Hematoma - Grade 1
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Hemoglobin - Grade 3 - *Possibly related
|
16.7%
3/18 • Number of events 4 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Hemoglobin - Grade 4 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Hemorrhage, GI - Lower GI NOS - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Hemorrhage, GI - Rectum - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Hemorrhage, GI - Upper GI - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Grade 1
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Cardiac disorders
Hypertension - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Infection - Grade 3
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Infections and infestations
Infection - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - lung - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (oral cavity) - Grade 3
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Nausea - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Pain - Cardiac/heart - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Pain - head/headache - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Pain: abdomen - Grade 2
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Platelets - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Platelets - Grade 4 - *Possibly related
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 2 - **Definitely related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 2 - *Possibly related
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Renal and urinary disorders
Renal failure - Grade 3
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Renal and urinary disorders
Renal failure - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Renal and urinary disorders
Renal/Genitourinary - Grade 2
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Vomiting - Grade 3 - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
Other adverse events
| Measure |
Dasatinib Dose Escalation
n=18 participants at risk
Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Neuropathy - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) - *Possibly related
|
5.6%
1/18 • Number of events 4 • 1 Year 4 Months
|
|
Eye disorders
Ocular/Visual - *1 Event possibly related
|
22.2%
4/18 • Number of events 4 • 1 Year 4 Months
|
|
General disorders
Pain
|
16.7%
3/18 • Number of events 5 • 1 Year 4 Months
|
|
General disorders
Pain - Abdomen - *2 Events possibly related
|
16.7%
3/18 • Number of events 4 • 1 Year 4 Months
|
|
General disorders
Pain - Back
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Pain - Breast
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Pain - Chest wall - *1 Event possibly related
|
11.1%
2/18 • Number of events 3 • 1 Year 4 Months
|
|
General disorders
Pain - Extremity: limb
|
5.6%
1/18 • Number of events 3 • 1 Year 4 Months
|
|
General disorders
Pain - Head/headache - *4 Events possibly related
|
16.7%
3/18 • Number of events 6 • 1 Year 4 Months
|
|
General disorders
Pain - Joint - *Possibly related
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Pain - Oral cavity
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Pain - Throat/pharynx/larynx - *1 Event possibly related
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Platelets - *6 Events possibly related
|
33.3%
6/18 • Number of events 8 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - *Possibly related
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia) - *1 Event possibly related
|
11.1%
2/18 • Number of events 3 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - other
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Renal and urinary disorders
Renal failure - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Rigors/chills - *1 Event possibly related
|
16.7%
3/18 • Number of events 3 • 1 Year 4 Months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Supraventricular tachycardia
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
General disorders
Sweating (diaphoresis) - *1 Event possibly related
|
16.7%
3/18 • Number of events 3 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Vomiting - *Possibly related
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Weight loss - *Possibly related
|
16.7%
3/18 • Number of events 3 • 1 Year 4 Months
|
|
Immune system disorders
Alergic rhinitis
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Anorexia - *2 Events possibly related
|
16.7%
3/18 • Number of events 3 • 1 Year 4 Months
|
|
Ear and labyrinth disorders
Auditory/Ear
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia) - *2 Events possibly related
|
33.3%
6/18 • Number of events 6 • 1 Year 4 Months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Cardiac disorders
Cardiac troponia I (cTnl)
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Constipation - *3 Events possibly related
|
22.2%
4/18 • Number of events 4 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough - *3 Events possibly related
|
22.2%
4/18 • Number of events 5 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Dehydration - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Dermatology
|
27.8%
5/18 • Number of events 6 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Diarrhea - *5 Events possibly related
|
44.4%
8/18 • Number of events 8 • 1 Year 4 Months
|
|
General disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Dysgeusia - *4 Events possibly related
|
16.7%
3/18 • Number of events 5 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - *6 Events possibly related
|
44.4%
8/18 • Number of events 14 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Edema: limb - *3 Events possbily related
|
22.2%
4/18 • Number of events 4 • 1 Year 4 Months
|
|
General disorders
Fatigue - *13 Events possibly related
|
66.7%
12/18 • Number of events 20 • 1 Year 4 Months
|
|
Infections and infestations
Febrile neutropenia - *3 Events possibly related
|
22.2%
4/18 • Number of events 4 • 1 Year 4 Months
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Flushing - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Gastrointestinal - other - *3 Events possibly related
|
27.8%
5/18 • Number of events 9 • 1 Year 4 Months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.6%
1/18 • Number of events 3 • 1 Year 4 Months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Hemoglobin - *11 Events possibly related
|
33.3%
6/18 • Number of events 12 • 1 Year 4 Months
|
|
General disorders
Hemorrhage, GI - Oral cavity
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Hemorrhage, GI - Rectum - *1 Event possibly related
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
General disorders
Hemorrhage, pulmonary/upper respiratory - Lung - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Cardiac disorders
Hypertension
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Infection - other - *2 Events possibly related
|
22.2%
4/18 • Number of events 6 • 1 Year 4 Months
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Urinary tract - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Skin - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus - *1 Event possibly related
|
11.1%
2/18 • Number of events 3 • 1 Year 4 Months
|
|
General disorders
Insomnia
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Iron overload
|
5.6%
1/18 • Number of events 2 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) - *Possibly related
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Blood and lymphatic system disorders
Lymphatics
|
11.1%
2/18 • Number of events 2 • 1 Year 4 Months
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Mucositis/stomatitis - Oral cavity - *Possibly related
|
5.6%
1/18 • Number of events 1 • 1 Year 4 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - *2 Events possibly related
|
11.1%
2/18 • Number of events 3 • 1 Year 4 Months
|
|
Gastrointestinal disorders
Nausea - *Possibly related
|
33.3%
6/18 • Number of events 6 • 1 Year 4 Months
|
Additional Information
Alan F. List, Executive Vice President & President, Moffitt Medical Group
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-6086
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place