Trial Outcomes & Findings for Vorinostat in Treating Patients With Acute Myeloid Leukemia (NCT NCT00305773)
NCT ID: NCT00305773
Last Updated: 2014-05-19
Results Overview
The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants. According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC \> 1500/mL, platelets \> 100000/mL, no circulating blasts, bone marrow cellularity \>20% (biopsy), trilineage maturation, \< 5% bone marrow blasts, no auer rods and no extramedullary disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2014-05-19
Participant Flow
A total of 37 participants were enrolled into this trial between January 2006 and August 2007. One patient on Arm A was ineligible; this participant was included in all analyses.
Participant milestones
| Measure |
Arm A (Once Daily Vorinostat)
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
22
|
|
Overall Study
COMPLETED
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
14
|
18
|
Reasons for withdrawal
| Measure |
Arm A (Once Daily Vorinostat)
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Alternative Treatment
|
4
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Disease Progression
|
1
|
3
|
|
Overall Study
All other reasons
|
3
|
2
|
Baseline Characteristics
Vorinostat in Treating Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Once Daily Vorinostat)
n=15 Participants
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 Participants
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Disease status
Relapsed
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Disease status
Untreated
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
AML disease classification
Relapsed AML with good risk cytogenetics
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
AML disease classification
All other relapsed AML
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
AML disease classification
Untreated AML patients >= 65 years old
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
AML disease classification
Untreated AML patients with MDS-AML
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
AML disease classification
Untreated AML with >= 3 cytogenetic abnnormalities
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants. According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC \> 1500/mL, platelets \> 100000/mL, no circulating blasts, bone marrow cellularity \>20% (biopsy), trilineage maturation, \< 5% bone marrow blasts, no auer rods and no extramedullary disease.
Outcome measures
| Measure |
Arm A (Once Daily Vorinostat)
n=15 Participants
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 Participants
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Confirmed Complete Response (CR) Rate
|
0 percentage of participants
Interval 0.0 to 23.0
|
4.5 percentage of participants
Interval 0.4 to 24.0
|
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Population: This data was not (and will never be) analyzed. In place of this outcome, time to treatment failure, analyzed and reported as a secondary outcome.
Time to Progression (TTP) for each patient will be calculated as the number of days from date of registration to either date when disease progression was documented or date of last evaluation without disease progression. The TTP distribution will be estimated using the method of Kaplan-Meier
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm A (Once Daily Vorinostat)
n=15 Participants
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 Participants
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
105 days
Interval 55.0 to 223.0
|
153 days
Interval 58.0 to 229.0
|
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
Outcome measures
| Measure |
Arm A (Once Daily Vorinostat)
n=15 Participants
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 Participants
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events
|
10 participants
|
17 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of treatment (up to 17 cycles)Time to treatment failure (TTF) was defined as the time from registration to until the date of treatment discontinuation of any reason. Patients receiving treatment at the time of analysis were considered censored. The median TTF with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm A (Once Daily Vorinostat)
n=15 Participants
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 Participants
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
42 days
Interval 26.0 to 57.0
|
46 days
Interval 20.0 to 71.0
|
Adverse Events
Arm A (Once Daily Vorinostat)
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm B (Thrice Daily Vorinostat)
Serious events: 16 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Once Daily Vorinostat)
n=15 participants at risk
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 participants at risk
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
13.3%
2/15 • Number of events 2
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Cecal obstruction
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15
|
18.2%
4/22 • Number of events 4
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
6.7%
1/15 • Number of events 2
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Death NOS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Disease progression
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 3
|
31.8%
7/22 • Number of events 7
|
|
General disorders
General symptom
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Sudden death
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Creatine phosphokinase increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1
|
18.2%
4/22 • Number of events 4
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 3
|
0.00%
0/22
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Vascular disorders
Thrombosis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
Arm A (Once Daily Vorinostat)
n=15 participants at risk
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Thrice Daily Vorinostat)
n=22 participants at risk
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 2
|
13.6%
3/22 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
46.7%
7/15 • Number of events 13
|
27.3%
6/22 • Number of events 11
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15
|
9.1%
2/22 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 4
|
50.0%
11/22 • Number of events 24
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 8
|
59.1%
13/22 • Number of events 15
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1
|
31.8%
7/22 • Number of events 7
|
|
General disorders
Chest pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Edema limbs
|
0.00%
0/15
|
9.1%
2/22 • Number of events 5
|
|
General disorders
Fatigue
|
80.0%
12/15 • Number of events 22
|
68.2%
15/22 • Number of events 52
|
|
General disorders
Pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 2
|
|
Infections and infestations
Opportunistic infection
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Investigations
INR increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Investigations
Leukocyte count decreased
|
40.0%
6/15 • Number of events 10
|
18.2%
4/22 • Number of events 12
|
|
Investigations
Neutrophil count decreased
|
86.7%
13/15 • Number of events 25
|
86.4%
19/22 • Number of events 45
|
|
Investigations
Platelet count decreased
|
93.3%
14/15 • Number of events 28
|
86.4%
19/22 • Number of events 55
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
4/15 • Number of events 5
|
40.9%
9/22 • Number of events 19
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
1/15 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Ataxia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
|
4.5%
1/22 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
1/15 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
6/15 • Number of events 7
|
31.8%
7/22 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.7%
1/15 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
13.3%
2/15 • Number of events 2
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/15
|
9.1%
2/22 • Number of events 2
|
|
Vascular disorders
Hematoma
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.00%
0/15
|
4.5%
1/22 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60