Trial Outcomes & Findings for Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma (NCT NCT02232516)
NCT ID: NCT02232516
Last Updated: 2024-04-10
Results Overview
The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Assessed after cycles 3 and 6, then every 6 months up to 3 years
Results posted on
2024-04-10
Participant Flow
The target population for this phase II study is patients with histologically confirmed (previously untreated) peripheral T-cell lymphoma (PTCL). Northwestern University will serve was the lead site and coordinating center for this study. Participating sites included Weill Cornell Medical College, and City of Hope. Enrollment began on 06/11/2015 at Northwestern University, 05/24/2017 at City of Hope, 12/14/2016 at Cornell University.
Participant milestones
| Measure |
Treatment (Romidepsin, Lenalidomide)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Study Treatment Period: Cycles 1-3
STARTED
|
30
|
|
Study Treatment Period: Cycles 1-3
Cycle 1
|
29
|
|
Study Treatment Period: Cycles 1-3
Cycle 2
|
23
|
|
Study Treatment Period: Cycles 1-3
Cycle 3
|
20
|
|
Study Treatment Period: Cycles 1-3
1st Response Assessment
|
23
|
|
Study Treatment Period: Cycles 1-3
COMPLETED
|
20
|
|
Study Treatment Period: Cycles 1-3
NOT COMPLETED
|
10
|
|
Study Treatment Period: Cycles 4-6
STARTED
|
20
|
|
Study Treatment Period: Cycles 4-6
Cycle 4
|
15
|
|
Study Treatment Period: Cycles 4-6
Cycle 5
|
13
|
|
Study Treatment Period: Cycles 4-6
Cycle 6
|
13
|
|
Study Treatment Period: Cycles 4-6
2nd Response Assessment
|
12
|
|
Study Treatment Period: Cycles 4-6
COMPLETED
|
13
|
|
Study Treatment Period: Cycles 4-6
NOT COMPLETED
|
7
|
|
Study Treatment Period: Cycles 7-9
STARTED
|
13
|
|
Study Treatment Period: Cycles 7-9
Cycle 7
|
6
|
|
Study Treatment Period: Cycles 7-9
Cycle 8
|
4
|
|
Study Treatment Period: Cycles 7-9
Cycle 9
|
3
|
|
Study Treatment Period: Cycles 7-9
3rd Response Assessment
|
3
|
|
Study Treatment Period: Cycles 7-9
COMPLETED
|
3
|
|
Study Treatment Period: Cycles 7-9
NOT COMPLETED
|
10
|
|
Study Treatment Period: Cycles 10-12
STARTED
|
3
|
|
Study Treatment Period: Cycles 10-12
Cycle 10
|
3
|
|
Study Treatment Period: Cycles 10-12
Cycle 11
|
3
|
|
Study Treatment Period: Cycles 10-12
Cycle 12
|
1
|
|
Study Treatment Period: Cycles 10-12
COMPLETED
|
1
|
|
Study Treatment Period: Cycles 10-12
NOT COMPLETED
|
2
|
|
Survival Follow-up
STARTED
|
29
|
|
Survival Follow-up
COMPLETED
|
5
|
|
Survival Follow-up
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Treatment (Romidepsin, Lenalidomide)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Study Treatment Period: Cycles 1-3
Adverse Event
|
6
|
|
Study Treatment Period: Cycles 1-3
Withdrawal by Subject
|
1
|
|
Study Treatment Period: Cycles 1-3
No Response
|
1
|
|
Study Treatment Period: Cycles 1-3
Screen failure
|
1
|
|
Study Treatment Period: Cycles 1-3
Disease Progression
|
1
|
|
Study Treatment Period: Cycles 4-6
Disease Progression
|
4
|
|
Study Treatment Period: Cycles 4-6
Adverse Event
|
1
|
|
Study Treatment Period: Cycles 4-6
Withdrawal by Subject
|
2
|
|
Study Treatment Period: Cycles 7-9
Adverse Event
|
4
|
|
Study Treatment Period: Cycles 7-9
Disease Progression
|
2
|
|
Study Treatment Period: Cycles 7-9
Withdrawal by Subject
|
3
|
|
Study Treatment Period: Cycles 7-9
Physician Decision
|
1
|
|
Study Treatment Period: Cycles 10-12
Adverse Event
|
1
|
|
Study Treatment Period: Cycles 10-12
Disease Progression
|
1
|
|
Survival Follow-up
Death
|
15
|
|
Survival Follow-up
Withdrawal by Subject
|
3
|
|
Survival Follow-up
Lost to Follow-up
|
1
|
|
Survival Follow-up
Still in follow-up
|
5
|
Baseline Characteristics
Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=29 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Customized
Age at Registration
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Stage
I
|
1 Participants
n=5 Participants
|
|
Stage
II
|
1 Participants
n=5 Participants
|
|
Stage
III
|
14 Participants
n=5 Participants
|
|
Stage
IV
|
13 Participants
n=5 Participants
|
|
International Prognostic Index (IPI) Score
|
3 units on a scale
n=5 Participants
|
|
Baseline LDH
|
224 U/L
n=5 Participants
|
|
Subtype
Adult T-Cell Leukemia/lymphoma
|
2 Participants
n=5 Participants
|
|
Subtype
Angioimmunoblastic T-cell Lymphoma
|
16 Participants
n=5 Participants
|
|
Subtype
Enteropathy-type T-cell Lymphoma
|
1 Participants
n=5 Participants
|
|
Subtype
Peripheral T-cell Lymphoma, unspecified
|
10 Participants
n=5 Participants
|
|
International Prognostic Index (IPI) Score - Discrete
1
|
1 Participants
n=5 Participants
|
|
International Prognostic Index (IPI) Score - Discrete
2
|
6 Participants
n=5 Participants
|
|
International Prognostic Index (IPI) Score - Discrete
3
|
10 Participants
n=5 Participants
|
|
International Prognostic Index (IPI) Score - Discrete
4
|
11 Participants
n=5 Participants
|
|
International Prognostic Index (IPI) Score - Discrete
5
|
1 Participants
n=5 Participants
|
|
Bone Marrow Involvement
Indeterminate
|
1 Participants
n=5 Participants
|
|
Bone Marrow Involvement
Negative
|
5 Participants
n=5 Participants
|
|
Bone Marrow Involvement
Not Done
|
16 Participants
n=5 Participants
|
|
Bone Marrow Involvement
Positive
|
7 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
8 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
14 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed after cycles 3 and 6, then every 6 months up to 3 yearsThe endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.
Outcome measures
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=23 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Response Rate (ORR), as Defined Per Cheson Criteria
CR + PR
|
15 participants
|
|
Objective Response Rate (ORR), as Defined Per Cheson Criteria
Complete Response (CR)
|
6 participants
|
|
Objective Response Rate (ORR), as Defined Per Cheson Criteria
Partial Response (PR)
|
9 participants
|
|
Objective Response Rate (ORR), as Defined Per Cheson Criteria
Stable Disease (SD)
|
2 participants
|
|
Objective Response Rate (ORR), as Defined Per Cheson Criteria
Progressive Disease (PD)
|
6 participants
|
SECONDARY outcome
Timeframe: Evaluated once per cycle (1 cycle=28 days) up to 1 year.The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution. Grade 3 or greater AEs that occurred in at least 10% of the patients are reported here
Outcome measures
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=29 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyponatremia
|
13 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypertension
|
11 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypokalemia
|
4 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperglycemia
|
4 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Blood Bilirubin Increased
|
4 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dehydration
|
3 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Thrombocytopenia
|
10 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anemia
|
8 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lung Infection
|
3 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Sepsis
|
3 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypoalbuminemia
|
7 Participants
|
|
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fatigue
|
5 Participants
|
SECONDARY outcome
Timeframe: Reported at 1 and 3 years after the start of treatmentl be progression-free survival (PFS) 1 and 3 years after start of treatment as well as the duration of response from start of therapy, defined per Cheson criteria.
Outcome measures
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=23 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival (PFS)
PFS at year 1
|
0.486 PFS Probability
Interval 0.311 to 0.759
|
|
Progression-free Survival (PFS)
PFS at year 3
|
0.315 PFS Probability
Interval 0.108 to 0.615
|
SECONDARY outcome
Timeframe: Reported at 1 and 2 years after the start of treatmentSurvival is defined as the duration of time from start of treatment to time of death, up to three years from the start of study treatment. Overall Survival (OS) is reported below as the proportion of patients who are alive at 1 and 2 years after starting treatment.
Outcome measures
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=23 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS)
OS at year 1
|
0.711 OS Probablilty
Interval 0.54 to 0.937
|
|
Overall Survival (OS)
OS at year 2
|
0.495 OS Probablilty
Interval 0.316 to 0.778
|
SECONDARY outcome
Timeframe: Assessed from start of therapy for up to 3 yearsThe duration of overall response is measured from the time measurement criteria are met for Complete Remission or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=15 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Duration of Response, Defined Per Cheson Criteria
|
324 Days
Interval 8.0 to 1035.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: This endpoint was not analyzed. No data was collected to analyze this endpoint.
Time to first cytotoxic chemotherapy is defined as the time (in months) from start of study treatment to time of first dose of anti-neoplastic cytotoxic chemotherapy that is administered to treat lymphoma.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsTo evaluate the use of NM PET/CT vs CT imaging in PTCL, a review of the utilized imaging modalities during treatment as a tool of response assessment will be done. When both imaging modalities are chosen for a patient, response assessment will be compared.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsClinical biomarkers including age, race, histology, and stage as an assessment of prognosis. A points based system will be used to correlate with recently developed prognostic model.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTo investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response. Archived tissue samples collected at baseline will be evaluated in order to determine how marker expression correlates with clinical outcome.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Romidepsin, Lenalidomide)
Serious events: 23 serious events
Other events: 29 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=29 participants at risk
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Colitis
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Chills
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Death NOS
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Edema limbs
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Fatigue
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Fever
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Lung infection
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Upper respiratory infection
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Platelet count decreased
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Presyncope
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Thromboembolic event
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
Other adverse events
| Measure |
Treatment (Romidepsin, Lenalidomide)
n=29 participants at risk
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
lenalidomide: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
89.7%
26/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Palpitations
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Sinus bradycardia
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Sinus tachycardia
|
27.6%
8/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Eye disorders
Blurred vision
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Eye disorders
Conjunctivitis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Eye disorders
Watering eyes
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
20.7%
6/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Anal pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Bloating
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Cheilitis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Constipation
|
65.5%
19/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Diarrhea
|
48.3%
14/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Dry mouth
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Nausea
|
75.9%
22/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Rectal pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Stomach pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Toothache
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
9/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Chills
|
24.1%
7/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Edema face
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Edema limbs
|
41.4%
12/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Fatigue
|
69.0%
20/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Fever
|
37.9%
11/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Gait disturbance
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Hypothermia
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Injection site reaction
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Localized edema
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Malaise
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Multi-organ failure
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Non-cardiac chest pain
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
General disorders
Pain
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Immune system disorders
Allergic reaction
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Lung infection
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Papulopustular rash
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Rhinitis infective
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Scrotal infection
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Skin infection
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Upper respiratory infection
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
20.7%
6/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Alanine aminotransferase increased
|
20.7%
6/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Alkaline phosphatase increased
|
37.9%
11/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Aspartate aminotransferase increased
|
37.9%
11/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Blood bilirubin increased
|
48.3%
14/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Cholesterol high
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Creatinine increased
|
41.4%
12/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Hemoglobin increased
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
INR increased
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Investigations - Other, specify
|
20.7%
6/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Lymphocyte count decreased
|
89.7%
26/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Neutrophil count decreased
|
69.0%
20/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Platelet count decreased
|
93.1%
27/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
Weight loss
|
44.8%
13/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Investigations
White blood cell decreased
|
69.0%
20/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
51.7%
15/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
51.7%
15/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
89.7%
26/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
75.9%
22/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.8%
4/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
62.1%
18/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
65.5%
19/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
89.7%
26/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.6%
8/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Concentration impairment
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Dizziness
|
27.6%
8/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Dysgeusia
|
37.9%
11/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Headache
|
20.7%
6/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Nervous system disorders
Tremor
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Psychiatric disorders
Anxiety
|
27.6%
8/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Psychiatric disorders
Confusion
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Psychiatric disorders
Depression
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Psychiatric disorders
Insomnia
|
24.1%
7/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Hematuria
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Proteinuria
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Urinary frequency
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.4%
12/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.0%
9/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.3%
3/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
24.1%
7/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
17.2%
5/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.9%
11/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.1%
7/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
24.1%
7/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Flushing
|
6.9%
2/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Hypertension
|
69.0%
20/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Hypotension
|
24.1%
7/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Lymphedema
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Phlebitis
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.4%
1/29 • The reporting time frame for Adverse Events and Serious Adverse Events is from the time of consent through 30 days after treatment discontinuation, up to 1 year. The reporting time frame for All Cause Mortality is up to 2 years after staring treatment
|
Additional Information
Dr. Jonathan Moreira
Northwestern University, Feinberg School of Medicine
Phone: 312-695-6180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place