Trial Outcomes & Findings for A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) (NCT NCT00619099)
NCT ID: NCT00619099
Last Updated: 2013-10-24
Results Overview
Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement. Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Remission: 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 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%. Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5%. Marrow Complete Remission: 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. HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Up to one year
Results posted on
2013-10-24
Participant Flow
This study was recruited at 5 centers in U.S. during the period of Jun 2008 to Aug 2011.
Participant milestones
| Measure |
Schedule A: SQ 3 Consecutive Days
Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Schedule B: SQ Once Every 7 Days
Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
23
|
|
Overall Study
Received at Least 2 Cycles of Treatment
|
43
|
22
|
|
Overall Study
COMPLETED
|
11
|
4
|
|
Overall Study
NOT COMPLETED
|
33
|
19
|
Reasons for withdrawal
| Measure |
Schedule A: SQ 3 Consecutive Days
Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Schedule B: SQ Once Every 7 Days
Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
7
|
5
|
|
Overall Study
Allogeneic Bone Marrow Transplantation
|
2
|
1
|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Emergence of Clinically Significant Lab
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
2
|
|
Overall Study
Physician Decision
|
9
|
6
|
Baseline Characteristics
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
Baseline characteristics by cohort
| Measure |
Schedule A: SQ 3 Consecutive Days
n=43 Participants
Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Schedule B: SQ Once Every 7 Days
n=22 Participants
Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.9 years
STANDARD_DEVIATION 14.39 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 9.86 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
55 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one yearPopulation: Modified Intent to Treat (mITT) Population
Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement. Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Remission: 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 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%. Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5%. Marrow Complete Remission: 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. HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response.
Outcome measures
| Measure |
Schedule A: SQ 3 Consecutive Days
n=43 Participants
Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Schedule B: SQ Once Every 7 Days
n=22 Participants
Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
|---|---|---|
|
The Overall Improvement Rate
Overall Improvement Rate
|
23.3 Percentage of Participants
|
22.7 Percentage of Participants
|
|
The Overall Improvement Rate
Complete Response
|
16.3 Percentage of Participants
|
0 Percentage of Participants
|
|
The Overall Improvement Rate
Marrow Complete Response
|
0 Percentage of Participants
|
4.5 Percentage of Participants
|
|
The Overall Improvement Rate
Partial Response
|
0 Percentage of Participants
|
4.5 Percentage of Participants
|
|
The Overall Improvement Rate
Hematologic Improvement
|
7.0 Percentage of Participants
|
13.6 Percentage of Participants
|
Adverse Events
Schedule A: SQ 3 Consecutive Days
Serious events: 18 serious events
Other events: 43 other events
Deaths: 0 deaths
Schedule B: SQ Once Every 7 Days
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Schedule A: SQ 3 Consecutive Days
n=43 participants at risk
Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Schedule B: SQ Once Every 7 Days
n=22 participants at risk
Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.7%
2/43
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/43
|
4.5%
1/22
|
|
Infections and infestations
Cellulitis
|
2.3%
1/43
|
4.5%
1/22
|
|
Infections and infestations
Streptococcal bacteremia
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Diverticulitis
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Neutropenia sepsis
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Pseudomonal sepsis
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43
|
9.1%
2/22
|
|
Infections and infestations
Infection worsening
|
2.3%
1/43
|
0.00%
0/22
|
|
Infections and infestations
Sepsis
|
0.00%
0/43
|
4.5%
1/22
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/43
|
4.5%
1/22
|
|
Infections and infestations
Appendicitis
|
0.00%
0/43
|
4.5%
1/22
|
|
Infections and infestations
Escherichia bacteremia
|
0.00%
0/43
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
2.3%
1/43
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/43
|
4.5%
1/22
|
|
Eye disorders
Conjunctival hemorrhage
|
2.3%
1/43
|
0.00%
0/22
|
|
Eye disorders
Retinal hemorrhage
|
2.3%
1/43
|
0.00%
0/22
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.3%
1/43
|
0.00%
0/22
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/43
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43
|
4.5%
1/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome worsening
|
0.00%
0/43
|
4.5%
1/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
0.00%
0/43
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/43
|
0.00%
0/22
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/43
|
4.5%
1/22
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.3%
1/43
|
0.00%
0/22
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.3%
1/43
|
0.00%
0/22
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43
|
0.00%
0/22
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
4.7%
2/43
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43
|
0.00%
0/22
|
|
Cardiac disorders
Angina pectoris
|
2.3%
1/43
|
0.00%
0/22
|
|
Cardiac disorders
Angina unstable
|
2.3%
1/43
|
0.00%
0/22
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/43
|
4.5%
1/22
|
|
General disorders
Pyrexia
|
2.3%
1/43
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
2.3%
1/43
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Head injury
|
2.3%
1/43
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/43
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/43
|
4.5%
1/22
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/43
|
4.5%
1/22
|
|
Surgical and medical procedures
Stem cell transplant
|
2.3%
1/43
|
0.00%
0/22
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/43
|
4.5%
1/22
|
Other adverse events
| Measure |
Schedule A: SQ 3 Consecutive Days
n=43 participants at risk
Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
Schedule B: SQ Once Every 7 Days
n=22 participants at risk
Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
55.8%
24/43
|
40.9%
9/22
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
3/43
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Leukopenia
|
41.9%
18/43
|
45.5%
10/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.8%
27/43
|
68.2%
15/22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.9%
18/43
|
54.5%
12/22
|
|
Eye disorders
Vision blurred
|
4.7%
2/43
|
9.1%
2/22
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43
|
13.6%
3/22
|
|
Gastrointestinal disorders
Constipation
|
14.0%
6/43
|
27.3%
6/22
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
7/43
|
27.3%
6/22
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/43
|
9.1%
2/22
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/43
|
9.1%
2/22
|
|
Gastrointestinal disorders
Mouth hemorrhage
|
0.00%
0/43
|
9.1%
2/22
|
|
Gastrointestinal disorders
Nausea
|
27.9%
12/43
|
13.6%
3/22
|
|
Gastrointestinal disorders
Oral pain
|
9.3%
4/43
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
4/43
|
9.1%
2/22
|
|
General disorders
Asthenia
|
11.6%
5/43
|
9.1%
2/22
|
|
General disorders
Chills
|
9.3%
4/43
|
0.00%
0/22
|
|
General disorders
Edema peripheral
|
16.3%
7/43
|
22.7%
5/22
|
|
General disorders
Fatigue
|
39.5%
17/43
|
45.5%
10/22
|
|
General disorders
Injection site pain
|
16.3%
7/43
|
18.2%
4/22
|
|
General disorders
Injection site reaction
|
2.3%
1/43
|
9.1%
2/22
|
|
General disorders
Pyrexia
|
32.6%
14/43
|
27.3%
6/22
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
7.0%
3/43
|
4.5%
1/22
|
|
Infections and infestations
Cellulitis
|
4.7%
2/43
|
9.1%
2/22
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
3/43
|
4.5%
1/22
|
|
Infections and infestations
Pneumonia
|
7.0%
3/43
|
13.6%
3/22
|
|
Infections and infestations
Sinusitis
|
7.0%
3/43
|
4.5%
1/22
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/43
|
13.6%
3/22
|
|
Infections and infestations
Urinary tract infection
|
16.3%
7/43
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Contusion
|
14.0%
6/43
|
18.2%
4/22
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
3/43
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/43
|
9.1%
2/22
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
7.0%
3/43
|
0.00%
0/22
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
4/43
|
4.5%
1/22
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
5/43
|
9.1%
2/22
|
|
Investigations
Blood creatinine increased
|
9.3%
4/43
|
18.2%
4/22
|
|
Investigations
Blood urea increased
|
4.7%
2/43
|
18.2%
4/22
|
|
Investigations
Cardiac murmur
|
11.6%
5/43
|
22.7%
5/22
|
|
Investigations
Transaminases increased
|
0.00%
0/43
|
9.1%
2/22
|
|
Investigations
Weight decreased
|
16.3%
7/43
|
22.7%
5/22
|
|
Investigations
Weight increased
|
4.7%
2/43
|
13.6%
3/22
|
|
Metabolism and nutrition disorders
Decreaed appetite
|
11.6%
5/43
|
40.9%
9/22
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.3%
10/43
|
13.6%
3/22
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.0%
3/43
|
22.7%
5/22
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.3%
1/43
|
13.6%
3/22
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.0%
3/43
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.0%
3/43
|
13.6%
3/22
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.0%
3/43
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.9%
12/43
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/43
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
9.3%
4/43
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.3%
4/43
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.3%
4/43
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.6%
5/43
|
13.6%
3/22
|
|
Nervous system disorders
Dizziness
|
25.6%
11/43
|
27.3%
6/22
|
|
Nervous system disorders
Headache
|
18.6%
8/43
|
9.1%
2/22
|
|
Nervous system disorders
Hypoaesthesia
|
11.6%
5/43
|
9.1%
2/22
|
|
Nervous system disorders
Memory impairment
|
4.7%
2/43
|
9.1%
2/22
|
|
Nervous system disorders
Somnolence
|
7.0%
3/43
|
0.00%
0/22
|
|
Nervous system disorders
Tremor
|
4.7%
2/43
|
9.1%
2/22
|
|
Psychiatric disorders
Anxiety
|
7.0%
3/43
|
0.00%
0/22
|
|
Psychiatric disorders
Insomnia
|
11.6%
5/43
|
13.6%
3/22
|
|
Renal and urinary disorders
Hematuria
|
7.0%
3/43
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.6%
5/43
|
27.3%
6/22
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/43
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.3%
7/43
|
36.4%
8/22
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.0%
3/43
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.6%
5/43
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
2.3%
1/43
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/43
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.3%
1/43
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.0%
3/43
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
3/43
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.0%
3/43
|
18.2%
4/22
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.0%
3/43
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
14.0%
6/43
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.3%
4/43
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.7%
2/43
|
13.6%
3/22
|
|
Surgical and medical procedures
Sinus operation
|
9.3%
4/43
|
0.00%
0/22
|
|
Vascular disorders
Hypertension
|
7.0%
3/43
|
0.00%
0/22
|
|
Vascular disorders
Hypotension
|
9.3%
4/43
|
13.6%
3/22
|
|
Vascular disorders
Orthostatic hypotension
|
7.0%
3/43
|
0.00%
0/22
|
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