Trial Outcomes & Findings for Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) (NCT NCT01259856)
NCT ID: NCT01259856
Last Updated: 2019-04-30
Results Overview
Number of participants with Complete Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Complete remission means no evidence of disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
12 months
Results posted on
2019-04-30
Participant Flow
Enrollment period from Sept 2011 through June 2016
Participant milestones
| Measure |
PEGASYS
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
86
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
69
|
74
|
Reasons for withdrawal
| Measure |
PEGASYS
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
9
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Treatment never started
|
0
|
6
|
|
Overall Study
Study closure by sponsor
|
40
|
41
|
|
Overall Study
Patient developed other disease
|
0
|
1
|
|
Overall Study
Transfer to another study
|
0
|
1
|
|
Overall Study
Unknown/missing
|
2
|
2
|
Baseline Characteristics
Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
Baseline characteristics by cohort
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 14.8 • n=39 Participants
|
61.8 years
STANDARD_DEVIATION 12.8 • n=41 Participants
|
59.4 years
STANDARD_DEVIATION 14.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
70 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
98 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=39 Participants
|
70 Participants
n=41 Participants
|
146 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Age > 60 years
|
42 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
98 Participants
n=35 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
65 Participants
n=39 Participants
|
72 Participants
n=41 Participants
|
137 Participants
n=35 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
15 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
3+
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Disease Type
Essential thrombocythemia (ET)
|
39 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Disease Type
Polycythemia Vera (PV)
|
43 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
87 Participants
n=35 Participants
|
|
Previous Thrombosis
|
26 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Previous Hemorrhage
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Splenomegaly
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Disease Duration
|
2.6 months
n=39 Participants
|
3.0 months
n=41 Participants
|
2.8 months
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV
Number of participants with Complete Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Complete remission means no evidence of disease.
Outcome measures
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Number of Participants With Complete Remission (CR)
Essential Thrombocythemia
|
17 Participants
|
19 Participants
|
|
Number of Participants With Complete Remission (CR)
Polycythemia Vera
|
12 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV
Number of participants with Partial Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Partial Remission means decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
Outcome measures
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Number of Participants With Partial Remission (PR)
Essential Thrombocythemia
|
10 Participants
|
11 Participants
|
|
Number of Participants With Partial Remission (PR)
Polycythemia Vera
|
25 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 4 yearsNumber of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).
Outcome measures
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events
Grade 3 Hematological event
|
3 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events
Grade 4 Hematological event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events
Grade 3 Non-hematological event
|
27 Participants
|
14 Participants
|
|
Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events
Grade 4 Non-hematological event
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline and 12 monthsChange in the Total Symptom Score which assessed improvement in disease symptoms measured by the change in TSS from the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) instrument being used in this study from baseline to 12 months. This 19 item instrument includes the previously validated 9 item brief fatigue inventory (BFI), symptoms related to splenomegaly, inactivity, cough, night sweats, pruritus, bone pains, fevers, weight loss, and an overall quality of life assessment. Each item is scored from 0-10 with full scale from 0-190, with higher scores mean worse symptoms.
Outcome measures
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Change in the Total Symptom Score (TSS)
|
1.16 score on a scale
Interval -2.04 to 4.36
|
-1.0 score on a scale
Interval -4.38 to 2.39
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: data not collected
To compare the impact of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) on key biomarkers of the disease(s) by measuring the JAK2 allele burden.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: data not collected
The impact of PEGASYS on JAK2 will be measured by the allele burden; hematopoietic cell clonality will be measured by whether patients with clonal disease return to polyclonal; bone marrow histopathology will be measured by going from abnormal to normal; cytogenetic abnormalities will be measured by seeing if the cytogenetics go from abnormal to normal.To compare the impact of therapy on JAK2-V617F (JAK2), CALR, hematopoietic cell clonality in platelets and granulocytes in females, bone marrow histopathology, and cytogenetic abnormalities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsSurvival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy To estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) by capturing the rate of progression to a more advanced myeloid malignancy.
Outcome measures
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Number of Participants With Progression of Disease or Death
Death
|
0 Participants
|
1 Participants
|
|
Number of Participants With Progression of Disease or Death
Progression to MF
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
PEGASYS
n=82 Participants
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 Participants
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Number of Participants With Major Cardiovascular Events After Therapy
|
1 Participants
|
1 Participants
|
Adverse Events
PEGASYS
Serious events: 14 serious events
Other events: 79 other events
Deaths: 0 deaths
Hydroxyurea
Serious events: 4 serious events
Other events: 76 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PEGASYS
n=82 participants at risk
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 participants at risk
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Infections and infestations
Infections - pathogen unspecified
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Hepatobiliary disorders
Bile Duct Disorder
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Cardiac disorders
Cardiac arrhythmias
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Cardiac disorders
Cardiac disorder signs and symptoms
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Metabolism and nutrition disorders
Electrolyte and fluid balance conditions
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Exocrine pancreas conditions
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrahges NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
General disorders
General system disorders NEC
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Headaches
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Blood and lymphatic system disorders
Platelet disorders
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, labour, delivery and postpartum conditions
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory and mediastinal neoplasms malignant and unspecified
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue infections and infestations
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Hepatobiliary disorders
Gallbladder disorders
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
Other adverse events
| Measure |
PEGASYS
n=82 participants at risk
The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
Hydroxyurea
n=86 participants at risk
Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.
Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distenstion
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Abdominal hernias and other abdominal wall conditions
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
General disorders
Administration site reactions
|
18.3%
15/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Injury, poisoning and procedural complications
Administration site reactions
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Investigations
Alanine aminotransferace increased
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Immune system disorders
Allergic conditions
|
1.2%
1/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Blood and lymphatic system disorders
Anaemias nonhaemolytic and marrow depression
|
12.2%
10/82 • 4 years
|
11.6%
10/86 • 4 years
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Psychiatric disorders
Anxeity disorders and symptoms
|
4.9%
4/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Metabolism and nutrition disorders
Appetite and general nutrition disorders
|
8.5%
7/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Vascular disorders
Arteriosclerosis, stenosis, vascular insufficiency and necrosis
|
1.2%
1/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Ear and labyrinth disorders
Aural disorders NEC
|
8.5%
7/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Infections and infestations
Bacterial infectious disorders
|
8.5%
7/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Gastrointestinal disorders
Benign neoplasms gastrointestinal
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Renal and urinary disorders
Bladder and bladder neck disorders (excl calculi)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
General disorders
Body temperature conditions
|
4.9%
4/82 • 4 years
|
5.8%
5/86 • 4 years
|
|
Injury, poisoning and procedural complications
Bone and joint injuries
|
7.3%
6/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone disorders (excl congenital and fractures)
|
3.7%
3/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Metabolism and nutrition disorders
Bone, calcium, magnesium and phosphorus metabolism disorders
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Cardiac disorders
Cardiac Signs and Symptoms NEC
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Cardiac and vascular investigations (excl enzyme tests)
|
0.00%
0/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Cardiac disorders
Cardiac arrhythmias
|
1.2%
1/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Cardiac disorders
Cardiac disorder signs and symptoms
|
13.4%
11/82 • 4 years
|
7.0%
6/86 • 4 years
|
|
Nervous system disorders
Central nervous system vascular disorders
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Cardiac disorders
Chest pain
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Blood and lymphatic system disorders
Coagulopathies and bleeding diatheses (excl thrombocytopenic)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Psychiatric disorders
Cognitive and attention disorders and disturbances
|
2.4%
2/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Cardiac disorders
Coronary artery disorders
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Cranial nerve disorders (excl neoplasms)
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Cutaneous neoplasms benign
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Vascular disorders
Decreased and nonspecific blood pressure disorders and shock
|
2.4%
2/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Gastrointestinal disorders
Dental and gingival conditions
|
4.9%
4/82 • 4 years
|
5.8%
5/86 • 4 years
|
|
Psychiatric disorders
Depressed mood disorders and disturbances
|
13.4%
11/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Psychiatric disorders
Depression
|
1.2%
1/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis and eczema
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin, other
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Diarrhoea (excl infective)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Diverticular disorders
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Dysgeusia
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Metabolism and nutrition disorders
Electrolyte and fluid balance conditions
|
4.9%
4/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Investigations
Elevated ALT
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Endocrine disorders
Endocrine disorders of gonadal function
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Enzyme investigations NEC
|
2.4%
2/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Epidermal and Dermal Conditions
|
29.3%
24/82 • 4 years
|
22.1%
19/86 • 4 years
|
|
Gastrointestinal disorders
Exocrine pancreas conditions
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Eye disorders
Eye disorders NEC
|
7.3%
6/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
General disorders
Fatigue
|
3.7%
3/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
General disorders
Fatigue or Tiredness
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
General disorders
Flu-like symptoms
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Infections and infestations
Fungal infectious disorders
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Hepatobiliary disorders
Gallbladder disorders
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal conditions NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal infections
|
0.00%
0/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal inflammatory conditions
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal motility and defaecation conditions
|
19.5%
16/82 • 4 years
|
23.3%
20/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
29.3%
24/82 • 4 years
|
20.9%
18/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal stenosis and obstruction
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal vascular conditions
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
General disorders
General malaise
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
General disorders
General system disorders NEC
|
61.0%
50/82 • 4 years
|
48.8%
42/86 • 4 years
|
|
Renal and urinary disorders
Genitourinary tract disorders NEC
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Endocrine disorders
Glucose metabolism disorders (incl diabetes mellitus)
|
4.9%
4/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Metabolism and nutrition disorders
Glucose metabolism disorders (incl diabetes mellitus)
|
4.9%
4/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Investigations
Haematology investigations (incl blood groups)
|
13.4%
11/82 • 4 years
|
14.0%
12/86 • 4 years
|
|
Blood and lymphatic system disorders
Haematopoietic neoplasms (excl leukaemias and lymphomas)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Headache
|
19.5%
16/82 • 4 years
|
12.8%
11/86 • 4 years
|
|
Ear and labyrinth disorders
Hearing disorders
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Cardiac disorders
Heart failures
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Hepatobiliary disorders
Hepatic and hepatobiliary disorders
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Hepatobiliary investigations
|
14.6%
12/82 • 4 years
|
5.8%
5/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Vascular disorders
Hypertension
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Infections and infestations
Infections - Pathogen Unspecified
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Infections and infestations
Infections - pathogen class unspecified
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Infections and infestations
Infections - pathogen unspecified
|
14.6%
12/82 • 4 years
|
8.1%
7/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Injury, poisoning and procedural complications
Injuries NEC
|
3.7%
3/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Ear and labyrinth disorders
Inner ear and VIIIth cranial nerve disorders
|
6.1%
5/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Investigations, imaging and histopathology procedures NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint Disorders
|
19.5%
16/82 • 4 years
|
10.5%
9/86 • 4 years
|
|
Investigations
Lipid analyses
|
3.7%
3/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Metabolism and nutrition disorders
Lipid metabolism disorders
|
4.9%
4/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Blood and lymphatic system disorders
Lymphomas non-Hodgkin's T-cell
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Reproductive system and breast disorders
Male reproductive tract infections and inflammations
|
2.4%
2/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Reproductive system and breast disorders
Menstrual cycle and uterine bleeding disorders
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Mental impairment disorders
|
1.2%
1/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Investigations
Metabolic, nutritional and blood gas investigations
|
2.4%
2/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Metabolism and nutrition disorders
Metabolic/laboratory, other
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Ear and labyrinth disorders
Middle ear disorders (excl congenital)
|
0.00%
0/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Nervous system disorders
Migraine
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Psychiatric disorders
Mood disorders and disturbances NEC
|
3.7%
3/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Nervous system disorders
Movement disorders (incl parkinsonism)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle disorders
|
11.0%
9/82 • 4 years
|
7.0%
6/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders NEC
|
20.7%
17/82 • 4 years
|
19.8%
17/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue neoplasms
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Cardiac disorders
Myocardial disorders
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Gastrointestinal disorders
nausea
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of colon
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Nervous system disorders
Nervous system disorders, unspecified
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Neurological disorders NEC
|
20.7%
17/82 • 4 years
|
17.4%
15/86 • 4 years
|
|
Nervous system disorders
Neurological signs and symptoms NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Eye disorders
Ocular haemorrhages and vascular disorders NEC
|
2.4%
2/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Eye disorders
Ocular infections, irritations and inflammations
|
11.0%
9/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Eye disorders
Ocular sensory symptoms NEC
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Eye disorders
Ocular surface disease
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Gastrointestinal disorders
Oral soft tissue conditions
|
3.7%
3/82 • 4 years
|
14.0%
12/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin disorders, Other
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Reproductive system and breast disorders
Penile and scrotal disorders (excl infections and inflammations)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Peripheral neuropathies
|
6.1%
5/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Investigations
Physical examination topics
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorders
|
0.00%
0/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Blood and lymphatic system disorders
Platelet disorders
|
8.5%
7/82 • 4 years
|
9.3%
8/86 • 4 years
|
|
Injury, poisoning and procedural complications
Procedural related injuries and complications NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Reproductive system and breast disorders
Prostatic disorders (excl infections and inflammations)
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Metabolism and nutrition disorders
Protein and amino acid metabolism disorders NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Metabolism and nutrition disorders
Purine and pyrimidine metabolism disorders
|
4.9%
4/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Investigations
Renal and urinary tract investigations and urinalyses
|
3.7%
3/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal and urinary tract neoplasms benign
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Renal and urinary disorders
Renal disorders (excl nephropathies)
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Reproductive neoplasms female benign
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders NEC
|
24.4%
20/82 • 4 years
|
14.0%
12/86 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infections
|
4.9%
4/82 • 4 years
|
11.6%
10/86 • 4 years
|
|
Eye disorders
Retina, choroid, and vitreous haemorrhages and vascular disorders
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Gastrointestinal disorders
Salivary gland conditions
|
6.1%
5/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Nervous system disorders
Sensory Abnormalities NEC
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Psychiatric disorders
Sexual dysfunctions, disturbances and gender identity disorders
|
2.4%
2/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Reproductive system and breast disorders
Sexual function and fertility disorders
|
1.2%
1/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders NEC
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue infections and infestations
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin appendage conditions
|
9.8%
8/82 • 4 years
|
8.1%
7/86 • 4 years
|
|
Investigations
Skin investigations
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasms malignant and unspecified
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin vascular abnormalities
|
2.4%
2/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Psychiatric disorders
Sleep disorders and disturbances
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Nervous system disorders
Sleep disturbances (incl subtypes)
|
7.3%
6/82 • 4 years
|
4.7%
4/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Blood and lymphatic system disorders
Spleen, lymphatic and reticuloendothelial system disorders
|
2.4%
2/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Synovial and bursal disorders
|
2.4%
2/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Tendon, ligament and cartilage disorders
|
2.4%
2/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Endocrine disorders
Thyroid gland disorders
|
4.9%
4/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Gastrointestinal disorders
Tongue conditions
|
3.7%
3/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract disorders (excl infections)
|
6.1%
5/82 • 4 years
|
5.8%
5/86 • 4 years
|
|
Infections and infestations
Upper respiratory tract infections - pathogen class unspecified
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Urinary Tract Infection
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Renal and urinary disorders
Urinary tract signs and symptoms
|
3.7%
3/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Renal and urinary disorders
Urolithiases
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Vascular disorders
Vascular disorders NEC
|
3.7%
3/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Vascular disorders
Vascular haemorrhagic disorders
|
1.2%
1/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Vascular disorders
Vascular hypertensive disorders
|
8.5%
7/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Vascular disorders
Venous varices
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Infections and infestations
Viral infectious disorders
|
3.7%
3/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Eye disorders
Vision disorders
|
9.8%
8/82 • 4 years
|
3.5%
3/86 • 4 years
|
|
Metabolism and nutrition disorders
Vitamin related disorders
|
0.00%
0/82 • 4 years
|
2.3%
2/86 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Investigations
Water, electrolyte and mineral investigations
|
2.4%
2/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Blood and lymphatic system disorders
White blood cell disorders
|
18.3%
15/82 • 4 years
|
7.0%
6/86 • 4 years
|
|
Eye disorders
blurred vision
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
General disorders
fatigue
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
General disorders
flu like symptoms
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Nervous system disorders
headache
|
1.2%
1/82 • 4 years
|
0.00%
0/86 • 4 years
|
|
Renal and urinary disorders
kidney stone
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Injury, poisoning and procedural complications
muscle, tendon, and ligament injuries
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
rashes, eruptions, and exanthems NEC
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous conditions NEC
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
skin appendage conditions
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
|
Skin and subcutaneous tissue disorders
skin appendage disorders
|
0.00%
0/82 • 4 years
|
1.2%
1/86 • 4 years
|
Additional Information
Dr. Ronald Hoffman
Icahn School of Medicine at Mount Sinai
Phone: 212-241-2296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place