Trial Outcomes & Findings for An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED) (NCT NCT00127101)
NCT ID: NCT00127101
Last Updated: 2015-04-21
Results Overview
Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Day 1 to day 28
Results posted on
2015-04-21
Participant Flow
Participant milestones
| Measure |
Cohort 1
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
|---|---|---|---|---|---|---|
|
Base Protocol
STARTED
|
3
|
5
|
3
|
3
|
5
|
4
|
|
Base Protocol
COMPLETED
|
1
|
1
|
1
|
3
|
3
|
3
|
|
Base Protocol
NOT COMPLETED
|
2
|
4
|
2
|
0
|
2
|
1
|
|
Continuation Phase
STARTED
|
0
|
0
|
1
|
0
|
3
|
3
|
|
Continuation Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Continuation Phase
NOT COMPLETED
|
0
|
0
|
1
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
|---|---|---|---|---|---|---|
|
Base Protocol
Adverse Event
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Base Protocol
Lack of Efficacy
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Base Protocol
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
0
|
1
|
|
Continuation Phase
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Continuation Phase
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Continuation Phase
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
1
|
Baseline Characteristics
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
n=5 Participants
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
n=5 Participants
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
n=4 Participants
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
26-35 years of age
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Age, Customized
36-45 years of age
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Age, Customized
46-55 years of age
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Age, Customized
56-65 years of age
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=8 Participants
|
9 participants
n=8 Participants
|
|
Age, Customized
66-75 years of age
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Age, Customized
Over 75 years of age
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity
Turkish
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity
White
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
4 participants
n=8 Participants
|
22 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 28Population: All Patients treated
Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
n=5 Participants
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
n=5 Participants
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
n=3 Participants
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
DLT
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
No DLT
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Every 28 days for up to 6 Months of TreatmentPopulation: All patients treated
Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score. SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
n=5 Participants
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
n=3 Participants
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
n=5 Participants
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
n=3 Participants
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Responded to Treatment
Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Responded to Treatment
No Response
|
3 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2a
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2b
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 7
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Infections and infestations
Lymph Node Abscess
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Lymphangitis
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis Fungoides
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-Cell Lymphoma
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
Other adverse events
| Measure |
Cohort 1
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2a
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 2b
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
|
Cohort 6
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
|
Cohort 7
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week \[150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)\]
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
60.0%
3/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
60.0%
3/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Anaemia Megaloblastic
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3
|
20.0%
1/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3
|
20.0%
1/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Endocrine disorders
Hypothyroidism
|
66.7%
2/3
|
60.0%
3/5
|
33.3%
1/3
|
66.7%
2/3
|
20.0%
1/5
|
75.0%
3/4
|
|
Eye disorders
Dry Eye
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Eye disorders
Eyelid Irritation
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Eye disorders
Vitreous Opacities
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3
|
40.0%
2/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
60.0%
3/5
|
50.0%
2/4
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Asthenia
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Chest Discomfort
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Fatigue
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
5/5
|
25.0%
1/4
|
|
General disorders
Feeling Cold
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Feeling Hot
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Pain
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Peripheral Coldness
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Ulcer
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Abscess Limb
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Anogenital Warts
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Gingival Infection
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Infections and infestations
Influenza
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Lymph Gland Infection
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
|
20.0%
1/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Infections and infestations
Puncture Site Infection
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Infections and infestations
Staphylococcal Skin Infection
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Infections and infestations
Superinfection
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/4
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/3
|
60.0%
3/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Investigations
Blood Sodium Increased
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/3
|
0.00%
0/5
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Investigations
Blood Urea Increased
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Body Temperature Increased
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Electrocardiogram ST Segment
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Electrocardiogram T Wave Inversion
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
High Density Lipoprotein Decreased
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Thyroxine Free Decreased
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Investigations
Tri-Iodothyronine Free Decreased
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Investigations
Weight Decreased
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
40.0%
2/5
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3
|
20.0%
1/5
|
33.3%
1/3
|
66.7%
2/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
100.0%
3/3
|
60.0%
3/5
|
66.7%
2/3
|
33.3%
1/3
|
20.0%
1/5
|
50.0%
2/4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Latent Autoimmune Diabetes In Adults
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3
|
20.0%
1/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/3
|
0.00%
0/5
|
66.7%
2/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
20.0%
1/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
33.3%
1/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/4
|
|
Nervous system disorders
Ageusia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
50.0%
2/4
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
20.0%
1/5
|
33.3%
1/3
|
33.3%
1/3
|
40.0%
2/5
|
0.00%
0/4
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/3
|
20.0%
1/5
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
25.0%
1/4
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
40.0%
2/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
33.3%
1/3
|
60.0%
3/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Alopecia Effluvium
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
60.0%
3/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
25.0%
1/4
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER