Trial Outcomes & Findings for Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain (NCT NCT01553916)
NCT ID: NCT01553916
Last Updated: 2018-07-05
Results Overview
-Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as \< 2 patients experiencing DLTs of the first 6 treated.
COMPLETED
PHASE1/PHASE2
19 participants
3 weeks
2018-07-05
Participant Flow
Participant milestones
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Pre-treatment MRI metastatic disease
|
1
|
Baseline Characteristics
Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain
Baseline characteristics by cohort
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=19 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: -Only patients enrolled in the safety lead-in were evaluable for this outcome measure
-Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as \< 2 patients experiencing DLTs of the first 6 treated.
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=6 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT)
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 6 participants were not evaluable for this outcome measure
* The HVLT is a word learning test measuring episodic visual memory * The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages) * The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall. * The words recalled for each trial were recorded and a total recall score tallied (range: 0-36). * The higher the score the better the recall
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=13 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score
|
20.0714 scores on a scale
Standard Deviation 8.29703
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 11 participants were not evaluable for this outcome measure
* The HVLT is a word learning test measuring episodic visual memory * The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages) * The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall. * The words recalled for each trial were recorded and a total recall score tallied (range: 0-36). * The higher the score the better the recall
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=8 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score
|
20.2 scores on a scale
Standard Deviation 7.22342
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 13 participants were not evaluable for this outcome measure
* The HVLT is a word learning test measuring episodic visual memory * The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages) * The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall. * The words recalled for each trial were recorded and a total recall score tallied (range: 0-36). * The higher the score the better the recall
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=6 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score
|
24.0 scores on a scale
Standard Deviation 4.89898
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: -8 participants were not evaluable for this outcome measure
* The HVLT is a word learning test measuring episodic visual memory * The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages) * The words were read aloud and the participants was asked to freely recall them 20-25 minutes later. * The words recalled were recorded and a total recall score tallied (range: 0-36). * The higher the score the better the recall
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=11 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score
|
8.6923 scores on a scale
Standard Deviation 2.89783
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 11 participants were not evaluable for this outcome measure
* The HVLT is a word learning test measuring episodic visual memory * The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages) * The words were read aloud and the participants was asked to freely recall them 20-25 minutes later. * The words recalled were recorded and a total recall score tallied (range: 0-36). * The higher the score the better the recall
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=8 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score
|
10.3 scores on a scale
Standard Deviation 1.56702
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 13 participants were not evaluable for this outcome measure
* The HVLT is a word learning test measuring episodic visual memory * The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages) * The words were read aloud and the participants was asked to freely recall them 20-25 minutes later. * The words recalled were recorded and a total recall score tallied (range: 0-36). * The higher the score the better the recall
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=6 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score
|
10.5 scores on a scale
Standard Deviation 0.83666
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 5 participants were not analyzed for this outcome measure
* Assessed by comparing questionnaire test scores to baseline; European Organization for Research and Treatment of Cancer (EORTC) QLQ30 (global health/QOL, cognitive functioning, and fatigue scales) * 30 total questions with 28 questions having answers ranging from 1-4 with 1=not at all and 4= very much and 2 questions ranging from 0-7 with 1-very poor and 7=excellent * Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score) * The higher the score the lower the quality of life
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=14 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30
|
45.0820 scores on a scale
Standard Deviation 7.4469
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 5 participants were not evaluable for this outcome measure
Assessed by comparing questionnaire test scores to baseline; BN20 (future uncertainty and communications deficit scales) * 20 questions with answers ranging from 1-4 with 1=not at all and 4=very much * Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score) * The higher the score the lower quality of life
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=14 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20
|
20.5514 scores on a scale
Standard Deviation 13.8067
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: (1) participant is not evaluable as the participant did not start treatment due to pre-treatment MRI showing metastatic disease in spine.
-Defined as at least 4 of 6 patients successfully completing pre-treatment and 3 month post-treatment testing
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=18 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: * 10 participants were evaluable for this outcome measure * Originally the outcome measure time frame was baseline through 12 months but there was insufficient data to statistically analyze the change in hippocampal morphology at 12 months due to the number of participants still alive for the 12 month scan.
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=10 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume
Baseline
|
6.13 cc
Interval 5.63 to 7.65
|
|
Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume
3 months
|
6.08 cc
Interval 4.95 to 6.69
|
|
Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume
12 months
|
6.34 cc
Interval 5.2 to 6.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 7 participants were not evaluable for this outcome measure
1-year rate of brain metastases
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=9 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Number of Participants With Brain Metastases
|
2 Participants
|
SECONDARY outcome
Timeframe: Through 12 monthsAdverse events will be tabulated by type and grade using NCI CTCAE v 4.
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=19 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Number of Central Nervous System (CNS) Adverse Events
Grade 1
|
28 CNS adverse events
|
|
Number of Central Nervous System (CNS) Adverse Events
Grade 2
|
6 CNS adverse events
|
|
Number of Central Nervous System (CNS) Adverse Events
Grade 3
|
2 CNS adverse events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 7 participants were not evaluable for this outcome measure
-Overall survival is defined as the time between date of on study and date of death due to any cause
Outcome measures
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=9 Participants
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Rate of Overall Survival
|
5 Participants
|
Adverse Events
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
n=19 participants at risk
Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.
PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.6%
6/19
|
|
Blood and lymphatic system disorders
Red blood cell decrease
|
5.3%
1/19
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
1/19
|
|
Ear and labyrinth disorders
External ear pain
|
5.3%
1/19
|
|
Ear and labyrinth disorders
Hearing impaired
|
10.5%
2/19
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
1/19
|
|
Endocrine disorders
Adrenal insufficiency
|
5.3%
1/19
|
|
Eye disorders
Blurred vision
|
10.5%
2/19
|
|
Eye disorders
Floaters
|
5.3%
1/19
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19
|
|
Gastrointestinal disorders
Nausea
|
47.4%
9/19
|
|
Gastrointestinal disorders
Vomiting
|
36.8%
7/19
|
|
General disorders
Chills
|
10.5%
2/19
|
|
General disorders
Edema face
|
5.3%
1/19
|
|
General disorders
Fatigue
|
57.9%
11/19
|
|
General disorders
Fever
|
10.5%
2/19
|
|
General disorders
Flu like symptoms
|
5.3%
1/19
|
|
General disorders
Gait disturbance
|
10.5%
2/19
|
|
General disorders
Malaise
|
5.3%
1/19
|
|
General disorders
Non-cardiac chest pain
|
5.3%
1/19
|
|
Infections and infestations
Bronchial infection
|
10.5%
2/19
|
|
Infections and infestations
Lung infection
|
10.5%
2/19
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
15.8%
3/19
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
5.3%
1/19
|
|
Investigations
Alanine aminotransferase increased
|
15.8%
3/19
|
|
Investigations
Alkaline phosphatase increased
|
5.3%
1/19
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19
|
|
Investigations
Creatinine increased
|
10.5%
2/19
|
|
Investigations
INR increased
|
5.3%
1/19
|
|
Investigations
Lymphocyte count decreased
|
47.4%
9/19
|
|
Investigations
Neutrophil count decreased
|
15.8%
3/19
|
|
Investigations
Platelet count decreased
|
10.5%
2/19
|
|
Investigations
Weight gain
|
5.3%
1/19
|
|
Investigations
Weight loss
|
15.8%
3/19
|
|
Investigations
White blood cell decreased
|
15.8%
3/19
|
|
Metabolism and nutrition disorders
Anorexia
|
36.8%
7/19
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.5%
2/19
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.5%
2/19
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.5%
2/19
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
2/19
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.8%
3/19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.1%
4/19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
3/19
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Other - sacroiliac pain
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Other - right leg pain
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other - disease progression
|
5.3%
1/19
|
|
Nervous system disorders
Concentration impairment
|
5.3%
1/19
|
|
Nervous system disorders
Dizziness
|
47.4%
9/19
|
|
Nervous system disorders
Dysgeusia
|
26.3%
5/19
|
|
Nervous system disorders
Headache
|
52.6%
10/19
|
|
Nervous system disorders
Memory impairment
|
10.5%
2/19
|
|
Nervous system disorders
Nystagmus
|
5.3%
1/19
|
|
Nervous system disorders
Other - myoclonic jerk
|
5.3%
1/19
|
|
Nervous system disorders
Paresthesia
|
5.3%
1/19
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.3%
1/19
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.5%
2/19
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19
|
|
Nervous system disorders
Tremor
|
10.5%
2/19
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19
|
|
Psychiatric disorders
Confusion
|
26.3%
5/19
|
|
Psychiatric disorders
Depression
|
10.5%
2/19
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.3%
5/19
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.3%
1/19
|
|
Vascular disorders
Thromboembolic event
|
5.3%
1/19
|
Additional Information
Clifford Robinson, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place