Trial Outcomes & Findings for To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS. (NCT NCT01011283)
NCT ID: NCT01011283
Last Updated: 2014-10-29
Results Overview
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10\^9/L; Neutrophils ≥ 1.0 X 10\^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
13 Weeks
Results posted on
2014-10-29
Participant Flow
This study was recruited at 20 centers in U.S. during the period of Feb 2010 to Jan 2011.
Participant milestones
| Measure |
Decitabine 20 mg/m^2
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
Decitabine 20 mg/m^2
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Progressive Disease
|
0
|
2
|
|
Overall Study
Terminated by Sponsor
|
5
|
5
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
Baseline characteristics by cohort
| Measure |
Decitabine 20 mg/m^2
n=13 Participants
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
n=13 Participants
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 9.13 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 WeeksPopulation: Intent to Treat Population
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10\^9/L; Neutrophils ≥ 1.0 X 10\^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
Outcome measures
| Measure |
Decitabine 20 mg/m^2
n=11 Participants
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
n=12 Participants
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
|---|---|---|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Overall Response Rate
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Complete Response
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Marrow Complete Response
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Partial Response
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Stable Disease
|
45.5 Percentage of Participants
|
25.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 36 WeeksPopulation: Intent to Treat Population
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10\^9/L; Neutrophils ≥ 1.0 X 10\^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
Outcome measures
| Measure |
Decitabine 20 mg/m^2
n=11 Participants
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
n=12 Participants
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
|---|---|---|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Overall Response Rate
|
9.1 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Complete Response
|
9.1 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Marrow Complete Response
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Partial Response
|
9.1 Percentage of Participants
|
0 Percentage of Participants
|
|
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
Stable Disease
|
36.4 Percentage of Participants
|
16.7 Percentage of Participants
|
Adverse Events
Decitabine 20 mg/m^2
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Azacitidine 75 mg/m^2
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine 20 mg/m^2
n=13 participants at risk
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
n=13 participants at risk
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
23.1%
3/13
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.4%
2/13
|
15.4%
2/13
|
|
Cardiac disorders
Thrombocytopenia
|
15.4%
2/13
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13
|
7.7%
1/13
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13
|
0.00%
0/13
|
|
Infections and infestations
Aspergillosis
|
7.7%
1/13
|
0.00%
0/13
|
|
Infections and infestations
Neutropenia sepsis
|
0.00%
0/13
|
7.7%
1/13
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/13
|
7.7%
1/13
|
|
Infections and infestations
Sepsis
|
7.7%
1/13
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.7%
1/13
|
0.00%
0/13
|
|
Nervous system disorders
Cerebrovascular accident
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/13
|
7.7%
1/13
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Pyrexia
|
0.00%
0/13
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/13
|
7.7%
1/13
|
Other adverse events
| Measure |
Decitabine 20 mg/m^2
n=13 participants at risk
decitabine : decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
|
Azacitidine 75 mg/m^2
n=13 participants at risk
azacitidine : azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
53.8%
7/13
|
38.5%
5/13
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.4%
2/13
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.8%
4/13
|
23.1%
3/13
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.2%
6/13
|
46.2%
6/13
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
46.2%
6/13
|
38.5%
5/13
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13
|
7.7%
1/13
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13
|
7.7%
1/13
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13
|
7.7%
1/13
|
|
Cardiac disorders
Tachycardia
|
15.4%
2/13
|
0.00%
0/13
|
|
Eye disorders
Erythema of eyelid
|
7.7%
1/13
|
0.00%
0/13
|
|
Eye disorders
Eye irritation
|
0.00%
0/13
|
15.4%
2/13
|
|
Eye disorders
Eye pain
|
0.00%
0/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13
|
23.1%
3/13
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
4/13
|
38.5%
5/13
|
|
Gastrointestinal disorders
Fecal incontinence
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Gingival pain
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13
|
69.2%
9/13
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
|
61.5%
8/13
|
|
General disorders
Asthenia
|
7.7%
1/13
|
15.4%
2/13
|
|
General disorders
Catheter site erythema
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
Catheter site pain
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
Chills
|
15.4%
2/13
|
7.7%
1/13
|
|
General disorders
Facial pain
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Fatigue
|
38.5%
5/13
|
53.8%
7/13
|
|
General disorders
Feeling jittery
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Injection site erythema
|
0.00%
0/13
|
30.8%
4/13
|
|
General disorders
Injection site hemorrhage
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Injection site edema
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Injection site pain
|
0.00%
0/13
|
23.1%
3/13
|
|
General disorders
Injection site rash
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Injection site reaction
|
0.00%
0/13
|
30.8%
4/13
|
|
General disorders
Nodule
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Edema peripheral
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Pain
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
Pyrexia
|
23.1%
3/13
|
15.4%
2/13
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/13
|
7.7%
1/13
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13
|
0.00%
0/13
|
|
Infections and infestations
Oral herpes
|
15.4%
2/13
|
0.00%
0/13
|
|
Infections and infestations
Paronchia
|
7.7%
1/13
|
0.00%
0/13
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13
|
7.7%
1/13
|
|
Infections and infestations
Skin infection
|
7.7%
1/13
|
0.00%
0/13
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/13
|
7.7%
1/13
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13
|
15.4%
2/13
|
|
Infections and infestations
Contusion
|
7.7%
1/13
|
7.7%
1/13
|
|
Infections and infestations
Post procedural discharge
|
0.00%
0/13
|
7.7%
1/13
|
|
Infections and infestations
Skin laceration
|
0.00%
0/13
|
7.7%
1/13
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
1/13
|
0.00%
0/13
|
|
Investigations
Blood potassium increased
|
0.00%
0/13
|
7.7%
1/13
|
|
Investigations
Blood pressure increased
|
0.00%
0/13
|
7.7%
1/13
|
|
Investigations
Breath sounds abnormal
|
7.7%
1/13
|
0.00%
0/13
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/13
|
7.7%
1/13
|
|
Investigations
Weight decreased
|
0.00%
0/13
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
2/13
|
23.1%
3/13
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/13
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/13
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/13
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/13
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13
|
15.4%
2/13
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/13
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
7.7%
1/13
|
0.00%
0/13
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/13
|
7.7%
1/13
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13
|
15.4%
2/13
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/13
|
7.7%
1/13
|
|
Nervous system disorders
Headache
|
15.4%
2/13
|
23.1%
3/13
|
|
Nervous system disorders
Memory impairment
|
7.7%
1/13
|
0.00%
0/13
|
|
Nervous system disorders
Syncope
|
7.7%
1/13
|
0.00%
0/13
|
|
Psychiatric disorders
Agitation
|
0.00%
0/13
|
7.7%
1/13
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13
|
15.4%
2/13
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13
|
7.7%
1/13
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13
|
7.7%
1/13
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13
|
0.00%
0/13
|
|
Renal and urinary disorders
Nocturia
|
7.7%
1/13
|
0.00%
0/13
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/13
|
7.7%
1/13
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13
|
7.7%
1/13
|
|
Renal and urinary disorders
Urinary retention
|
15.4%
2/13
|
0.00%
0/13
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
7.7%
1/13
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.00%
0/13
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/13
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.7%
1/13
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13
|
23.1%
3/13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13
|
15.4%
2/13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/13
|
15.4%
2/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway cough syndrome
|
7.7%
1/13
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.7%
1/13
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/13
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
15.4%
2/13
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/13
|
7.7%
1/13
|
|
Vascular disorders
Hypotension
|
7.7%
1/13
|
7.7%
1/13
|
Additional Information
Erhan Berrack, M.D.
Eisai Inc.
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place