Trial Outcomes & Findings for Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL (NCT NCT01145209)
NCT ID: NCT01145209
Last Updated: 2023-11-28
Results Overview
Death or disease progression defined by the 2008 IWCLL guideline as follows; * Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging * Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which was not previously present * Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5000/ul * Transformation to a more aggressive histology * Occurrence of any cytopenia attributable to CLL. After treatment: the progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 20 g/L (2 g/dL) or to less than 100 g/L (10 g/dL), or by a decrease of platelet counts by more than 50% or to les
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
2 years
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
FCO Arm (Fludarabine, Cyclophosphamide, and Ofatumumab)
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
FO Arm (Fludarabine and Ofatumumab)
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
19
|
|
Overall Study
COMPLETED
|
10
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL
Baseline characteristics by cohort
| Measure |
FO Arm (Fludarabine and Ofatumumab)
n=19 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm (Fludarabine, Cyclophosphamide, and Ofatumumab)
n=13 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The analyses included only those subjects who completed the induction period.
Death or disease progression defined by the 2008 IWCLL guideline as follows; * Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging * Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which was not previously present * Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5000/ul * Transformation to a more aggressive histology * Occurrence of any cytopenia attributable to CLL. After treatment: the progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 20 g/L (2 g/dL) or to less than 100 g/L (10 g/dL), or by a decrease of platelet counts by more than 50% or to les
Outcome measures
| Measure |
FO Arm
n=18 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=10 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Progression Free Survival Rate 2 Years After Initiation of Induction Therapy
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients included in safety analysis. It was pre-specified to recombine Arms/Groups for this assessment and report irrespective of randomized group.
Number of Grade 3 and 4 treatment related adverse events as defined by CTCAE version 3.0 criteria. CTCAE (Common Terminology Criteria for Adverse Events) provides a list of adverse event (AE) terms commonly reported. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 is a Mild AE; Grade 2 is a Moderate AE; Grade 3 is a Severe AE; Grade 4 is a Life-threatening or disabling AE; and Grade 5 is a Death related to AE
Outcome measures
| Measure |
FO Arm
n=32 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Number of Grade 3 and 4 Treatment Related Adverse Events
Neutropenia Grade 3
|
4 Number of Grade 3 and Grade 4 AEs
|
—
|
|
Number of Grade 3 and 4 Treatment Related Adverse Events
Thrombocytopenia Grade 3
|
2 Number of Grade 3 and Grade 4 AEs
|
—
|
|
Number of Grade 3 and 4 Treatment Related Adverse Events
Nausea Grade 3
|
1 Number of Grade 3 and Grade 4 AEs
|
—
|
|
Number of Grade 3 and 4 Treatment Related Adverse Events
Infusion reaction Grade 3
|
1 Number of Grade 3 and Grade 4 AEs
|
—
|
|
Number of Grade 3 and 4 Treatment Related Adverse Events
Neutropenia Grade 4
|
17 Number of Grade 3 and Grade 4 AEs
|
—
|
|
Number of Grade 3 and 4 Treatment Related Adverse Events
Lymphopenia Grade 4
|
2 Number of Grade 3 and Grade 4 AEs
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analyses included only those subjects who completed the induction period.
Participants with minimal residual disease (MRD) negativity following the completion of induction chemoimmunotherapy.
Outcome measures
| Measure |
FO Arm
n=18 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=10 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Participants With Minimal Residual Disease (MRD) Negativity
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who achieved MRD negativity at the completion of consolidation immunotherapy
Participants with MRD negativity at the completion of consolidation immunotherapy who failed to achieve MRD negativity following completion of induction chemoimmunotherapy
Outcome measures
| Measure |
FO Arm
n=14 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=4 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Participants With MRD Negativity at the Completion of Consolidation Immunotherapy Who Failed to Achieve MRD Negativity
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analyses included only those subjects who completed the induction period.
Participants with complete response rates to induction chemoimmunotherapy. Criteria for complete response (CR): CR requires all of the following: * Peripheral blood lymphocytes \< 4000/uL * Absence of significant lymphadenopathy by physical examination and appropriate radiographic techniques (CT or MRI). All lymph nodes must have regressed to \<=1.5cm in greatest diameter * Absence of hepatomegaly or splenomegaly by physical examination, or appropriate radiographic techniques. Spleen, if enlarged before therapy must have regressed in size and must not be palpable by physical exam. * Absence of constitutional symptoms * Normal CBC, defined as: - Polymorphonuclear cells ≥ 1,500/uL - Platelets \> 100,000/uL (untransfused) - Hemoglobin \> 11 g/dL (untransfused) * Bone marrow biopsy demonstrates normal cellularity for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent
Outcome measures
| Measure |
FO Arm
n=10 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=18 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Participants With Complete Response Rates Following Induction Chemoimmunotherapy.
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analyses included only those subjects who completed the induction period.
Participants with complete response rates to induction chemoimmunotherapy. Criteria for complete response (CR) requires all of the following: Peripheral blood lymphocytes \< 4000/uL. No significant lymphadenopathy. Lymph nodes regressed to \<=1.5cm. No hepatomegaly or splenomegaly. Spleen, if enlarged before therapy must have regressed in size and not be palpable. Absence of constitutional symptoms. Bone marrow biopsy demonstrates normal cellularity for age, with less than 30% of nucleated cells being lymphocytes. No lymphoid nodules. Criteria for partial response (PR) requires at least one element of an abnormal CBC and at least one of the following: ≥ 50% decrease in peripheral blood lymphocyte count; ≥ 50% reduction in the sum of the products of lymph nodes up to 6 nodes or nodal masses. No new sites or increase in size of nodes; ≥ 50% reduction in pathologic enlargement of the liver and/or spleen by 50%.
Outcome measures
| Measure |
FO Arm
n=10 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=18 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Participants Overall Response Rates Following Induction Chemoimmunotherapy.
Complete Response
|
6 Participants
|
2 Participants
|
|
Participants Overall Response Rates Following Induction Chemoimmunotherapy.
Partial Response
|
4 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The analyses included only those subjects who completed the induction period.
Participants overall survival rate 2 years after initiation of induction chemoimmunotherapy
Outcome measures
| Measure |
FO Arm
n=18 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=10 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Participants Overall Survival Rate After Initiation of Induction Chemoimmunotherapy
Alive
|
18 Participants
|
10 Participants
|
|
Participants Overall Survival Rate After Initiation of Induction Chemoimmunotherapy
Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analyses included only those subjects who completed the induction period. It was pre-specified to have arms/groups recombine for this assessment and report irrespective of randomized group.
Median relationship of biomarker, CD20 expression with MRD negativity clinical response rate. Flow cytometry was use to quantified surface CD20 on peripheral blood.
Outcome measures
| Measure |
FO Arm
n=18 Participants
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
FCO Arm
n=9 Participants
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
|---|---|---|
|
Median Relationship of CD20 Expression With MRD Negativity Rate
|
10247 sites per cell
Interval 2336.0 to 20956.0
|
15131 sites per cell
Interval 3323.0 to 55488.0
|
Adverse Events
FCO (Fludarabine, Cyclophosphamide, and Ofatumumab)
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
FO (Fludarabine and Ofatumumab)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FCO (Fludarabine, Cyclophosphamide, and Ofatumumab)
n=13 participants at risk
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
FO (Fludarabine and Ofatumumab)
n=19 participants at risk
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Pyrexia
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Injury, poisoning and procedural complications
Rib fracture
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Vascular disorders
Jugular vein thrombosis
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
Other adverse events
| Measure |
FCO (Fludarabine, Cyclophosphamide, and Ofatumumab)
n=13 participants at risk
Fludarabine, cyclophosphamide, and ofatumumab for patients with high-risk FISH changes
|
FO (Fludarabine and Ofatumumab)
n=19 participants at risk
Fludarabine and ofatumumab for patients with non-high-risk FISH changes
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Cardiac disorders
Chest pain
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Cardiac disorders
Dizziness
|
30.8%
4/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
21.1%
4/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Cardiac disorders
Dyspnea
|
23.1%
3/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Cardiac disorders
Oedema peripheral
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Ear and labyrinth disorders
Ear hemorrhage
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Endocrine disorders
Thyroid mass
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Eye disorders
Keratitis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
15.8%
3/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Dysgeusia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Gingival pain
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Nausea
|
84.6%
11/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
31.6%
6/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Oral candidiasis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Chills
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
15.8%
3/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Decreased appetite
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Fatigue
|
61.5%
8/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
57.9%
11/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Flushing
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Hyperhidrosis
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Influenza like illness
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Night sweats
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Oedema
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
General disorders
Pyrexia
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Hepatobiliary disorders
Hepatitis viral
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Immune system disorders
Hypersensitivity
|
38.5%
5/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
31.6%
6/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Immune system disorders
Rhinitis allergic
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Infections and infestations
Lung infection
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Infections and infestations
Upper respiratory tract infection
|
23.1%
3/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
47.4%
9/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
15.8%
3/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Injury, poisoning and procedural complications
Phlebitis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Hemoglobin
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Haptoglobin
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
International normalized ratio increased
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Neutrophil count decreased
|
69.2%
9/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
68.4%
13/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
Platelet count decreased
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Investigations
White blood cell count increased
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Metabolism and nutrition disorders
Osteopenia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Metabolism and nutrition disorders
Pica
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
38.5%
5/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
42.1%
8/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Abnormal dreams
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Cerebral ischemia
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Cognitive disorder
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Confusional state
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
31.6%
6/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Insomnia
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
36.8%
7/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
0.00%
0/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
21.1%
4/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
10.5%
2/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Rash
|
46.2%
6/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
26.3%
5/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
|
Vascular disorders
Hypotension
|
15.4%
2/13 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
5.3%
1/19 • 2 years
Based on CTCAE version 4 for non-hematologic toxicities and 2008 IWCLL guidelines for hematologic toxicities
|
Additional Information
Wiestner, Adrian MD, PhD
National Heart Lung and Blood Institute
Phone: +1.301.594.6855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place