Trial Outcomes & Findings for Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT02048813)
NCT ID: NCT02048813
Last Updated: 2025-11-13
Results Overview
PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as disease progression. * Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with \> 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \> 1.5 cm by physical exam.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
529 participants
Primary outcome timeframe
Assessed every 3 months until progression up to 4 years and 8 months
Results posted on
2025-11-13
Participant Flow
The study was activated on January 31, 2014 and closed to accrual on June 9, 2016. A total of 529 patients were enrolled on this study.
Participant milestones
| Measure |
Arm A (Ibrutinib, Rituximab)
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
354
|
175
|
|
Overall Study
COMPLETED
|
0
|
105
|
|
Overall Study
NOT COMPLETED
|
354
|
70
|
Reasons for withdrawal
| Measure |
Arm A (Ibrutinib, Rituximab)
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Still on treatment
|
279
|
0
|
|
Overall Study
Adverse Event
|
40
|
38
|
|
Overall Study
Disease progression
|
13
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Complication
|
2
|
2
|
|
Overall Study
Non-protocol therapy
|
0
|
1
|
|
Overall Study
Second primary cancer
|
2
|
0
|
|
Overall Study
Insurance
|
2
|
0
|
|
Overall Study
Wound infection/healing
|
2
|
0
|
|
Overall Study
Missed appointment
|
3
|
0
|
|
Overall Study
Never started treatment
|
2
|
17
|
Baseline Characteristics
Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A (Ibrutinib, Rituximab)
n=354 Participants
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=175 Participants
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 7.5 • n=10 Participants
|
56.7 years
STANDARD_DEVIATION 7.2 • n=10 Participants
|
56.7 years
STANDARD_DEVIATION 7.4 • n=20 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=10 Participants
|
55 Participants
n=10 Participants
|
173 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=10 Participants
|
120 Participants
n=10 Participants
|
356 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
333 Participants
n=10 Participants
|
167 Participants
n=10 Participants
|
500 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
29 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
318 Participants
n=10 Participants
|
160 Participants
n=10 Participants
|
478 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months until progression up to 4 years and 8 monthsPopulation: All randomized patients were included in this analysis.
PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as disease progression. * Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with \> 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \> 1.5 cm by physical exam.
Outcome measures
| Measure |
Arm A (Ibrutinib, Rituximab)
n=354 Participants
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=175 Participants
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival (PFS) Rate at 3 Years
|
0.894 Proportion of participants
Interval 0.86 to 0.93
|
0.729 Proportion of participants
Interval 0.653 to 0.813
|
SECONDARY outcome
Timeframe: Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5, up to 4 years and 8 monthsPopulation: All randomized patients were included in this analysis.
Overall survival was defined as time from randomization to death from any cause or date last known alive. Overall survival rate at 3 years was estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (Ibrutinib, Rituximab)
n=354 Participants
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=175 Participants
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) Rate at 3 Years
|
0.988 Proportion of participants
Interval 0.976 to 1.0
|
0.915 Proportion of participants
Interval 0.862 to 0.97
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsThe Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Trial Outcome Index (TOI) is comprised of the physical well-being (PWB) and functional well-being (FWB) components of the FACT-General (FACT-G) and the leukemia subscale. The FACT-Leu TOI contains a total of 31 items, with scores ranging from 0 to 124. The higher the score, the better the quality of life (QOL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 12 monthsThe Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Trial Outcome Index (TOI) is comprised of the physical well-being (PWB) and functional well-being (FWB) components of the FACT-General (FACT-G) and the leukemia subscale. The FACT-Leu TOI contains a total of 31 items, with scores ranging from 0 to 124. The higher the score, the better the quality of life (QOL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at baseline, every 3 months for the first 2 years, and every 6 months for years 3-5Patients are classified as stage 0-IV according to the Rai system and categorized into one of the three risk groups: Low risk - Stage 0 Intermediate risk - Stage I or II High risk - Stage III or IV CR requires all of the following for at least 2 months: * Absence of lymphadenopathy by physical examination on 2 occasions at least 4 weeks apart and appropriate radiographic techniques. For patients whose only measurable disease at the time of enrollment is on CT scan, a CT scan is required and all lymph nodes must be ≤ 1.5 cm before classifying the patient a CR. * Absence of hepatomegaly or splenomegaly by physical examination * Absence of constitutional symptoms due to disease * Normal complete blood count * One marrow aspirate and biopsy should be performed 52 weeks after Day 1 of cycle 1 among patients with clinical and laboratory evidence of a CR to document a CR. The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 3 months until progression up to 5 yearsPFS was defined as time from randomization to progression or death. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of ≥ 2 lymph nodes on 2 consecutive exams 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as progression. * Transformation to a more aggressive histology. For patients with a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \>1.5 cm by physical exam. MRD status was evaluated at 2 years and samples with \<=20 monotypic events or an MRD level of \<10\^-4 were classified as undetectable MRD.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline, and 3, 6, 12, 15, 18, 24, 36 monthsGenetic abnormalities are assessed at baseline and longitudinally during treatment as well as after treatment. Distribution of genetic abnormalities are reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at 12 monthsT-cell counts will be measured at 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5PFS was defined as time from randomization to progression or death, whichever occurred first. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of ≥2 lymph nodes on 2 consecutive examinations 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as progression. * Transformation to a more aggressive histology. For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \> 1.5 cm by physical exam. The distribution of PFS by SNPs will be reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5A prognostic model that incorporates clinical and biologic characters to predict PFS will be developed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline and 3, 6, 12, 15, 18, 24, 36 monthsEvaluation of signaling networks downstream of the B-cell receptor in patients receiving Ibrutinib-based therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at relapseCollection of relapse samples to study mechanisms of resistance to protocol treatments.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Ibrutinib, Rituximab)
Serious events: 270 serious events
Other events: 348 other events
Deaths: 4 deaths
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
Serious events: 132 serious events
Other events: 154 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm A (Ibrutinib, Rituximab)
n=352 participants at risk
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=158 participants at risk
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
16/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
15.8%
25/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
8/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
15.8%
25/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.2%
36/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Asystole
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
5.7%
20/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Atrial flutter
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
5/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Conduction disorder
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Heart failure
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Pericardial effusion
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Pericardial tamponade
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Sinus bradycardia
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Sinus tachycardia
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Chills
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Edema limbs
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fatigue
|
2.3%
8/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fever
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Infusion related reaction
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Multi-organ failure
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Pain
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.6%
9/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Colitis
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
9/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Enterocolitis infectious
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Hepatitis viral
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Lung infection
|
6.2%
22/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Papulopustular rash
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Penile infection
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Scrotal infection
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Sepsis
|
2.0%
7/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.2%
5/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Skin infection
|
1.4%
5/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Soft tissue infection
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
6/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Wound infection
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.5%
16/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
8/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
7/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
2.3%
8/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Creatinine increased
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Ejection fraction decreased
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
7.1%
25/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
65.2%
103/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Lymphocyte count increased
|
27.6%
97/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
13.9%
22/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
29.0%
102/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
45.6%
72/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Platelet count decreased
|
4.0%
14/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
16.5%
26/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Weight gain
|
1.1%
4/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
White blood cell decreased
|
6.5%
23/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
40.5%
64/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Investigations - Other, specify
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.1%
4/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
4/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
19/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
8/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, spe
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Cognitive disturbance
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Headache
|
1.1%
4/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Stroke
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Syncope
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.4%
5/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Depression
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Suicidal ideation
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
4/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, spe
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.57%
2/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hematoma
|
0.85%
3/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hypertension
|
12.5%
44/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hypotension
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
Other adverse events
| Measure |
Arm A (Ibrutinib, Rituximab)
n=352 participants at risk
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
|
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=158 participants at risk
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
52.0%
183/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
62.7%
99/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
27/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Palpitations
|
8.5%
30/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Chills
|
5.7%
20/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
10.8%
17/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Edema limbs
|
17.3%
61/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.9%
14/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fatigue
|
66.8%
235/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
66.5%
105/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fever
|
11.9%
42/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
20.3%
32/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Infusion related reaction
|
8.0%
28/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
24.7%
39/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Pain
|
6.2%
22/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
General disorders and administration site conditions - Other
|
7.4%
26/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
31/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.2%
5/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
29/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.1%
8/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
31.5%
111/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
10.1%
16/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
18.5%
65/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.2%
5/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
26/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
39/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
24.1%
38/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
41.5%
146/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
15.2%
24/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
25/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
34/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.2%
36/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
17.0%
60/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.6%
12/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
33.2%
117/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
60.8%
96/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
30/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
25.3%
40/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.1%
25/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Skin infection
|
6.2%
22/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
44/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.2%
13/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.5%
23/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.2%
117/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
13.9%
49/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
10.8%
17/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
10.5%
37/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
12.7%
20/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
17.3%
61/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
17.1%
27/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
19.9%
70/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
13.9%
22/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Creatinine increased
|
21.0%
74/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.9%
14/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
22.7%
80/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
50.6%
80/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Lymphocyte count increased
|
37.5%
132/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.6%
12/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
33.2%
117/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
50.6%
80/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Platelet count decreased
|
51.4%
181/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
65.8%
104/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Weight gain
|
7.1%
25/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
White blood cell decreased
|
21.0%
74/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
68.4%
108/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
39/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
17.7%
28/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
31/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.7%
9/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
21/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.6%
41/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.8%
6/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.0%
21/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.5%
4/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.9%
42/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
11.4%
18/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
19/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.8%
6/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.6%
9/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.0%
11/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.7%
108/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.8%
6/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
19/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.2%
5/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.8%
112/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
12.7%
20/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
25/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, spe
|
11.9%
42/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
12.5%
44/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
9.5%
15/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Dysgeusia
|
5.4%
19/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.7%
9/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Headache
|
25.3%
89/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
15.8%
25/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.6%
41/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.3%
10/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Eye disorders
Blurred vision
|
6.8%
24/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.9%
3/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Anxiety
|
3.4%
12/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.1%
8/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
7.7%
27/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
10.1%
16/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
36/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.0%
11/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
32/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
11.4%
18/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
27/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.63%
1/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
8.2%
29/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.3%
2/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Urinary frequency
|
0.28%
1/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.7%
9/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hypertension
|
29.8%
105/352 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.3%
10/158 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 4.5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60