Trial Outcomes & Findings for Panobinostat and Ruxolitinib In MyElofibrosis (PRIME Trial) (NCT NCT01693601)
NCT ID: NCT01693601
Last Updated: 2023-10-31
Results Overview
Number of patients that have either stable disease or clinical improvement treatment response as defined by the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Stable disease (SD) - response that is not complete remission, partial remission, clinical improvement, anemia response, spleen response, symptoms response, or progressive disease. Clinical improvement (CI) - a response in anemia, splenomegaly, or MF-SB that is not associated with progressive splenomegaly or increase in severity of anemia, thrombocytopenia, or neutropenia.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
at least 6 months
Results posted on
2023-10-31
Participant Flow
Participant milestones
| Measure |
Panobinostat and Ruxolitinib Cohort 1
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Cohort 1
STARTED
|
3
|
0
|
0
|
0
|
|
Cohort 1
COMPLETED
|
3
|
0
|
0
|
0
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2
STARTED
|
0
|
6
|
0
|
0
|
|
Cohort 2
COMPLETED
|
0
|
6
|
0
|
0
|
|
Cohort 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 3
STARTED
|
0
|
0
|
3
|
0
|
|
Cohort 3
COMPLETED
|
0
|
0
|
3
|
0
|
|
Cohort 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 4
STARTED
|
0
|
0
|
0
|
3
|
|
Cohort 4
COMPLETED
|
0
|
0
|
0
|
3
|
|
Cohort 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=6 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 Participants
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=3 Participants
|
61 years
n=6 Participants
|
69 years
n=3 Participants
|
64 years
n=3 Participants
|
64 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
11 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Disease subtype
Primary myelofibrosis (PMF)
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=15 Participants
|
|
Disease subtype
Post essential thrombocythemia PET-MF
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=15 Participants
|
|
Disease subtype
Post polycythemia vera PPV-MF
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
DIPSS Score
low (score 0)
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
DIPSS Score
intermediate-1 (score 1 or 2)
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=15 Participants
|
|
DIPSS Score
intermediate-2 (score 3 or 4)
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
8 Participants
n=15 Participants
|
|
JAK2^V617F positive
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
|
Cytogenetics
Unfavorable Karyotype
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Cytogenetics
Not Unfavorable Karyotype
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
11 Participants
n=15 Participants
|
|
Cytogenetics
Not available
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Prior Myelofibrous (MF) Directed Therapy
|
2 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=15 Participants
|
|
Ruxolitinib Naive
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
|
Prior No. Therapies
|
1 therapies
n=3 Participants
|
1.5 therapies
n=6 Participants
|
2 therapies
n=3 Participants
|
0 therapies
n=3 Participants
|
1 therapies
n=15 Participants
|
|
Red Blood Cell (RBC) Transfusion Dependent
Screening
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Red Blood Cell (RBC) Transfusion Dependent
Baseline - Cycle 1, Day 1 (C1D1) Rux +Pano
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=15 Participants
|
|
White Blood Cell (WBC)
Screening
|
11.3 10^3 cells/µl
n=3 Participants
|
9.8 10^3 cells/µl
n=6 Participants
|
9.8 10^3 cells/µl
n=3 Participants
|
34.3 10^3 cells/µl
n=3 Participants
|
12.5 10^3 cells/µl
n=15 Participants
|
|
White Blood Cell (WBC)
Baseline, C1D1
|
5.1 10^3 cells/µl
n=3 Participants
|
7 10^3 cells/µl
n=6 Participants
|
6 10^3 cells/µl
n=3 Participants
|
25.9 10^3 cells/µl
n=3 Participants
|
6.8 10^3 cells/µl
n=15 Participants
|
|
Hemoglobin (Hb)
Screening
|
9.1 g/DL
n=3 Participants
|
9.7 g/DL
n=6 Participants
|
10.5 g/DL
n=3 Participants
|
11.2 g/DL
n=3 Participants
|
9.8 g/DL
n=15 Participants
|
|
Hemoglobin (Hb)
Baseline, C1D1
|
8.4 g/DL
n=3 Participants
|
10.75 g/DL
n=6 Participants
|
10.1 g/DL
n=3 Participants
|
11.7 g/DL
n=3 Participants
|
10.4 g/DL
n=15 Participants
|
|
Platelet (PLT)
Screening
|
495 10^3 cells/µl
n=3 Participants
|
276 10^3 cells/µl
n=6 Participants
|
584 10^3 cells/µl
n=3 Participants
|
377 10^3 cells/µl
n=3 Participants
|
347 10^3 cells/µl
n=15 Participants
|
|
Platelet (PLT)
Baseline, C1D1
|
131 10^3 cells/µl
n=3 Participants
|
192.5 10^3 cells/µl
n=6 Participants
|
166 10^3 cells/µl
n=3 Participants
|
253 10^3 cells/µl
n=3 Participants
|
188 10^3 cells/µl
n=15 Participants
|
|
Palpable Spleen
Screening
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
13 Participants
n=15 Participants
|
|
Palpable Spleen
Baseline, C1D1
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
11 Participants
n=15 Participants
|
|
Palpable Spleen Length
Screening
|
6 cm
n=3 Participants
|
12.5 cm
n=6 Participants
|
10 cm
n=3 Participants
|
15 cm
n=3 Participants
|
13 cm
n=15 Participants
|
|
Palpable Spleen Length
Baseline, C1D1
|
6 cm
n=3 Participants
|
11 cm
n=6 Participants
|
0 cm
n=3 Participants
|
11 cm
n=3 Participants
|
10 cm
n=15 Participants
|
|
MRI Spleen Volume
|
1190 cm^3
n=3 Participants
|
2154.5 cm^3
n=6 Participants
|
2425 cm^3
n=3 Participants
|
1982 cm^3
n=3 Participants
|
2077 cm^3
n=15 Participants
|
PRIMARY outcome
Timeframe: at least 6 monthsNumber of patients that have either stable disease or clinical improvement treatment response as defined by the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Stable disease (SD) - response that is not complete remission, partial remission, clinical improvement, anemia response, spleen response, symptoms response, or progressive disease. Clinical improvement (CI) - a response in anemia, splenomegaly, or MF-SB that is not associated with progressive splenomegaly or increase in severity of anemia, thrombocytopenia, or neutropenia.
Outcome measures
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=6 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 Participants
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Number of Patients That Achieve Stable Disease or Clinical Improvement
Stable disease
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients That Achieve Stable Disease or Clinical Improvement
Clinical Improvement
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients That Achieve Stable Disease or Clinical Improvement
No response evaluated
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to cycle 6, day 29Panobinostat related adverse events requiring dose reduction or discontinuing prior to Cycle 6, Day 29 (C6D29)
Outcome measures
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=6 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 Participants
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting (DLTs)
requiring Panaobinostat dose reduction
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Dose-Limiting (DLTs)
Discontinuing Panobinostat
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Cycle 6, Day 29Population: One participant did not return for C6,D29 visit
Percent change in spleen volume at C6D29 as compared to baseline
Outcome measures
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=5 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 Participants
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Percent Change in Spleen Volume
|
-41 percent change
Interval -44.0 to -8.0
|
-8 percent change
Interval -61.0 to 25.0
|
-40 percent change
Interval -59.0 to 4.0
|
-17 percent change
Interval -29.0 to -15.0
|
SECONDARY outcome
Timeframe: Cycle 6, Day 29Percent change in spleen length size by palpation at cycle 6, day 29 (C6D29) from baseline
Outcome measures
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=12 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Percent Change in Spleen Size for Responders and Non-responders
|
-100 percent change
Interval -100.0 to -14.0
|
-29 percent change
Interval -100.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6, Day 29Population: One participant did not return for C6,D29 visit
Percent change in spleen length at C6D29
Outcome measures
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=5 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 Participants
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Percent Change in Spleen Length
|
-83 percent change
Interval -100.0 to -29.0
|
-17 percent change
Interval -100.0 to 0.0
|
-14 percent change
Interval -100.0 to 0.0
|
-31 percent change
Interval -33.0 to -29.0
|
SECONDARY outcome
Timeframe: baseline, C1D1 and Cycle 6 Day 29Population: C6D29 not available for one participant in cohort 2 and 2 participants in cohort 4
Symptom responders defined as having a percent change in MPN-SAF score from Screening/C1D1 to C6D29 of more than 50%.MPN-SAF is an 18-item instrument. Each item score 0-10 averaged, total scale from0-10, with higher score indicating more symptoms.
Outcome measures
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=5 Participants
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 Participants
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=1 Participants
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Number of Participants With Percent Change on Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Panobinostat and Ruxolitinib Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Panobinostat and Ruxolitinib Cohort 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Panobinostat and Ruxolitinib Cohort 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Panobinostat and Ruxolitinib Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 participants at risk
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=6 participants at risk
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 participants at risk
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 participants at risk
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
66.7%
2/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Night Sweats
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Oral Ulcers
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Product Issues
Ruxolitinib withdrawal
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate ca in situ
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Injury, poisoning and procedural complications
Wound complication post surgery
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Fever
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Infections and infestations
Infection
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Cardiac disorders
Supraventricula Tachycardia
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral PE
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
Other adverse events
| Measure |
Panobinostat and Ruxolitinib Cohort 1
n=3 participants at risk
Combination of Panobinostat 10mg and Ruxolitinib 10mg
|
Panobinostat and Ruxolitinib Cohort 2
n=6 participants at risk
Combination of Panobinostat 10mg and Ruxolitinib 15mg
|
Panobinostat and Ruxolitinib Cohort 3
n=3 participants at risk
Combination of Panobinostat 10mg and Ruxolitinib 20mg
|
Panobinostat and Ruxolitinib Cohort 4
n=3 participants at risk
Combination of Panobinostat 15mg and Ruxolitinib 15mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
66.7%
2/3 • 6 months
|
66.7%
2/3 • 6 months
|
|
Infections and infestations
Upper Respiratory Infection
|
33.3%
1/3 • 6 months
|
66.7%
4/6 • 6 months
|
66.7%
2/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • 6 months
|
50.0%
3/6 • 6 months
|
66.7%
2/3 • 6 months
|
66.7%
2/3 • 6 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
General disorders
Night Sweats
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 6 months
|
33.3%
2/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Oral Ulcers
|
33.3%
1/3 • 6 months
|
50.0%
3/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • 6 months
|
16.7%
1/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
66.7%
2/3 • 6 months
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 6 months
|
33.3%
2/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Nervous system disorders
Taste changes
|
0.00%
0/3 • 6 months
|
50.0%
3/6 • 6 months
|
33.3%
1/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Ankle Swelling
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Edema
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Fever
|
0.00%
0/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Blood and lymphatic system disorders
Spleen pain
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Investigations
Weight Gain
|
33.3%
1/3 • 6 months
|
16.7%
1/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • 6 months
|
16.7%
1/6 • 6 months
|
66.7%
2/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Chills
|
0.00%
0/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Renal and urinary disorders
Dysuria
|
66.7%
2/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Renal and urinary disorders
Frequent Urination
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Fungal Rash
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
66.7%
2/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
66.7%
2/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Nervous system disorders
Sciatica
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Lesion
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Clavicular Protuberance
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash/Infection
|
0.00%
0/3 • 6 months
|
33.3%
2/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Renal and urinary disorders
Prostatitis
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Blood and lymphatic system disorders
Bleeding (finger)
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Nervous system disorders
Dysphagia
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
100.0%
3/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Early Satiety
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Psychiatric disorders
Emotional lability
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Gum Bleeding
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
General disorders
Increased dental plaque
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Injury, poisoning and procedural complications
Broken tooth
|
33.3%
1/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Eye disorders
Blockage of left medial canthus
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Eye disorders
Blurry vision
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Investigations
Bilirubin increased
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Facial pain
|
33.3%
1/3 • 6 months
|
16.7%
1/6 • 6 months
|
33.3%
1/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Eye disorders
Eye itching (right)
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Grover's disease
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
0.00%
0/3 • 6 months
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Nipple pain
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Nocturnal myoclonic jerks
|
0.00%
0/3 • 6 months
|
16.7%
1/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
Additional Information
John Mascarenhas
Icahn School of Medicine at Mount Sinai
Phone: 212-241-3417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place