Trial Outcomes & Findings for Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia (NCT NCT00602459)
NCT ID: NCT00602459
Last Updated: 2023-05-22
Results Overview
Proportion of participants who were alive and progression free at 2 years.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
418 participants
Primary outcome timeframe
2 years
Results posted on
2023-05-22
Participant Flow
From January 2008 to August 2012, 418 participants were recruited to this study.
Participant milestones
| Measure |
Arm A (Rituximab, Fludarabine Phosphate)
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)
Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
|
|---|---|---|---|---|
|
Initial Registration/Randomization
STARTED
|
138
|
140
|
140
|
0
|
|
Initial Registration/Randomization
COMPLETED
|
133
|
130
|
137
|
0
|
|
Initial Registration/Randomization
NOT COMPLETED
|
5
|
10
|
3
|
0
|
|
Re-assignment After Del(11q22.3) Testing
STARTED
|
123
|
109
|
137
|
31
|
|
Re-assignment After Del(11q22.3) Testing
COMPLETED
|
123
|
109
|
137
|
31
|
|
Re-assignment After Del(11q22.3) Testing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Rituximab, Fludarabine Phosphate)
n=123 Participants
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)
n=109 Participants
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=137 Participants
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)
n=31 Participants
Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
261 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
8 participants
n=4 Participants
|
53 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
95 participants
n=7 Participants
|
121 participants
n=5 Participants
|
23 participants
n=4 Participants
|
347 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Patients re-assigned to Arm C were split into two analysis groups, patients with del(11q22.3), as assessed by interphase cytogenetics and present in at least 20% of cells, and those without del(11q22.3). This endpoint is limited to patients without del(11q22.3).
Proportion of participants who were alive and progression free at 2 years.
Outcome measures
| Measure |
Arm A, FR in Non-del(11q22.3)
n=123 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B, FR+L in Non-del(11q22.3)
n=109 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C1, FCR in Non-del(11q22.3)
n=110 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (C) (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
|---|---|---|---|
|
2-Year Progression Free Survival (PFS) Rate
|
0.64 proportion of participants
Interval 0.57 to 0.71
|
0.71 proportion of participants
Interval 0.63 to 0.78
|
0.74 proportion of participants
Interval 0.66 to 0.8
|
SECONDARY outcome
Timeframe: Up to 15 yearsPopulation: Patients without Del(11q22.3) were included in this analysis.
Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus \>= 1 of the following: \>= 1500/uL polymorphonuclear leukocytes, \> 100,000/uL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.
Outcome measures
| Measure |
Arm A, FR in Non-del(11q22.3)
n=123 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B, FR+L in Non-del(11q22.3)
n=109 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C1, FCR in Non-del(11q22.3)
n=110 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (C) (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
|---|---|---|---|
|
Overall Response Rate in Patients Without Del(11q22.3)
|
75 percentage of participants
Interval 68.0 to 81.0
|
69 percentage of participants
Interval 61.0 to 76.0
|
71 percentage of participants
Interval 63.0 to 78.0
|
SECONDARY outcome
Timeframe: Up to 15 yearsPopulation: Patients with del(11q22.3) were included in this analysis.
Percentage of del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus \>= 1 of the following: \>= 1500/uL polymorphonuclear leukocytes, \> 100,000/uL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.
Outcome measures
| Measure |
Arm A, FR in Non-del(11q22.3)
n=27 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B, FR+L in Non-del(11q22.3)
n=31 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C1, FCR in Non-del(11q22.3)
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (C) (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
|---|---|---|---|
|
Overall Response Rates in Patients With Del(11q22.3)
|
59 percentage of participants
Interval 42.0 to 75.0
|
74 percentage of participants
Interval 58.0 to 86.0
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: This endpoint is limited to patients with del(11q22.3).
Proportion of del (11q22.3) participants who were alive and progression free at 2 years.
Outcome measures
| Measure |
Arm A, FR in Non-del(11q22.3)
n=27 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B, FR+L in Non-del(11q22.3)
n=31 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C1, FCR in Non-del(11q22.3)
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (C) (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
|---|---|---|---|
|
PFS Rate of Patients With Del(11q22.3)
|
0.56 proportion of participants
Interval 0.38 to 0.72
|
0.65 proportion of participants
Interval 0.48 to 0.79
|
—
|
SECONDARY outcome
Timeframe: Up to 15 yearsPopulation: This endpoint is limited to patients without del(11q22.3).
Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: \>= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, \>= 50% increase in the product of at least two lymphnodes, \>= 50% increase in the enlargement of the liver and/or spleen.
Outcome measures
| Measure |
Arm A, FR in Non-del(11q22.3)
n=123 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B, FR+L in Non-del(11q22.3)
n=109 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C1, FCR in Non-del(11q22.3)
n=110 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (C) (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
|---|---|---|---|
|
Time-to-progression in Patients Without Del(11q22.3)
|
43.5 months
Interval 32.8 to 49.9
|
66.0 months
Interval 44.5 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
78.0 months
Interval 57.9 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
SECONDARY outcome
Timeframe: Up to 15 yearsPopulation: This endpoint is limited to patients with del(11q22.3).
Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm A, FR in Non-del(11q22.3)
n=27 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B, FR+L in Non-del(11q22.3)
n=31 Participants
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C1, FCR in Non-del(11q22.3)
Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (C) (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
|---|---|---|---|
|
Time-to-progression in Patients With Del(11q22.3)
|
35.5 months
Interval 21.8 to 65.5
|
44.6 months
Interval 25.7 to 50.7
|
—
|
Adverse Events
Arm A (Rituximab, Fludarabine Phosphate)
Serious events: 13 serious events
Other events: 117 other events
Deaths: 0 deaths
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)
Serious events: 21 serious events
Other events: 107 other events
Deaths: 0 deaths
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
Serious events: 14 serious events
Other events: 132 other events
Deaths: 0 deaths
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Rituximab, Fludarabine Phosphate)
n=123 participants at risk
Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)
n=109 participants at risk
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=137 participants at risk
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)
n=31 participants at risk
Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.81%
1/123 • Number of events 1
|
5.5%
6/109 • Number of events 6
|
2.9%
4/137 • Number of events 4
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.5%
8/123 • Number of events 8
|
13.8%
15/109 • Number of events 17
|
7.3%
10/137 • Number of events 10
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Premature ventricular contractions
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Sinus tachycardia
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Tinnitus
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/123 • Number of events 2
|
7.3%
8/109 • Number of events 8
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/123 • Number of events 2
|
2.8%
3/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Chest pain
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
General disorders
Chills
|
0.81%
1/123 • Number of events 1
|
6.4%
7/109 • Number of events 7
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
General disorders
Death NOS
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Disease progression
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Edema limbs
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 4
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Fatigue
|
6.5%
8/123 • Number of events 8
|
13.8%
15/109 • Number of events 17
|
4.4%
6/137 • Number of events 6
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/123
|
4.6%
5/109 • Number of events 5
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
General disorders
Localized edema
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Pain
|
1.6%
2/123 • Number of events 2
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/123
|
3.7%
4/109 • Number of events 4
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Bladder infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Bronchitis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Joint infection
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Infections and infestations
Sepsis
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Sinusitis
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Skin infection
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Vaginal infection
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Vulvitis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/123
|
4.6%
5/109 • Number of events 5
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Creatinine increased
|
0.00%
0/123
|
4.6%
5/109 • Number of events 5
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
INR increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Leukocyte count decreased
|
0.81%
1/123 • Number of events 1
|
6.4%
7/109 • Number of events 7
|
3.6%
5/137 • Number of events 5
|
0.00%
0/31
|
|
Investigations
Lymphocyte count decreased
|
0.81%
1/123 • Number of events 1
|
3.7%
4/109 • Number of events 4
|
2.9%
4/137 • Number of events 4
|
0.00%
0/31
|
|
Investigations
Neutrophil count decreased
|
5.7%
7/123 • Number of events 7
|
11.0%
12/109 • Number of events 14
|
5.8%
8/137 • Number of events 8
|
0.00%
0/31
|
|
Investigations
Platelet count decreased
|
7.3%
9/123 • Number of events 9
|
9.2%
10/109 • Number of events 12
|
6.6%
9/137 • Number of events 9
|
0.00%
0/31
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Weight loss
|
1.6%
2/123 • Number of events 2
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Anorexia
|
0.81%
1/123 • Number of events 1
|
4.6%
5/109 • Number of events 5
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
1.6%
2/123 • Number of events 2
|
8.3%
9/109 • Number of events 9
|
2.9%
4/137 • Number of events 4
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Dehydration
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Renal tubular disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
1.6%
2/123 • Number of events 2
|
4.6%
5/109 • Number of events 5
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.6%
2/123 • Number of events 2
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/123
|
3.7%
4/109 • Number of events 4
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.6%
2/123 • Number of events 2
|
4.6%
5/109 • Number of events 5
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
3.6%
5/137 • Number of events 5
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.6%
2/123 • Number of events 2
|
0.00%
0/109
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Ataxia
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123 • Number of events 1
|
3.7%
4/109 • Number of events 4
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Headache
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Syncope
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Psychiatric disorders
Agitation
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Psychiatric disorders
Confusion
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Psychiatric disorders
Depression
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
1.5%
2/137 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/123
|
0.92%
1/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Psychiatric disorders
Personality change
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Renal and urinary disorders
Renal failure
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Breast pain
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/123 • Number of events 2
|
7.3%
8/109 • Number of events 9
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
5/123 • Number of events 5
|
6.4%
7/109 • Number of events 7
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
1.6%
2/123 • Number of events 2
|
2.8%
3/109 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Flushing
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Vascular disorders
Hematoma
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Vascular disorders
Hot flashes
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Hypertension
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Vascular disorders
Hypotension
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Vascular disorders
Vascular disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
Other adverse events
| Measure |
Arm A (Rituximab, Fludarabine Phosphate)
n=123 participants at risk
Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
|
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)
n=109 participants at risk
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
|
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
n=137 participants at risk
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
|
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)
n=31 participants at risk
Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Hearing impaired
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
3.2%
1/31 • Number of events 3
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.81%
1/123 • Number of events 2
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Tinnitus
|
4.1%
5/123 • Number of events 16
|
0.00%
0/109
|
0.73%
1/137 • Number of events 6
|
0.00%
0/31
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Eye disorders
Cataract
|
0.00%
0/123
|
0.00%
0/109
|
2.2%
3/137 • Number of events 4
|
0.00%
0/31
|
|
Eye disorders
Conjunctivitis
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Eye disorders
Diplopia
|
0.00%
0/123
|
0.92%
1/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Eye disorders
Dry eye syndrome
|
0.81%
1/123 • Number of events 3
|
0.00%
0/109
|
1.5%
2/137 • Number of events 4
|
0.00%
0/31
|
|
Eye disorders
Eye disorder
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 4
|
0.00%
0/31
|
|
Eye disorders
Eye pain
|
2.4%
3/123 • Number of events 6
|
0.92%
1/109 • Number of events 2
|
0.73%
1/137 • Number of events 4
|
0.00%
0/31
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Eye disorders
Flashing vision
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 6
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Eye disorders
Keratitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Eye disorders
Photophobia
|
0.00%
0/123
|
3.7%
4/109 • Number of events 5
|
0.00%
0/137
|
3.2%
1/31 • Number of events 4
|
|
Eye disorders
Retinopathy
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Eye disorders
Vision blurred
|
4.9%
6/123 • Number of events 7
|
7.3%
8/109 • Number of events 10
|
2.9%
4/137 • Number of events 4
|
0.00%
0/31
|
|
Eye disorders
Vitreous hemorrhage
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Eye disorders
Watering eyes
|
0.00%
0/123
|
0.92%
1/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal distension
|
0.81%
1/123 • Number of events 1
|
3.7%
4/109 • Number of events 7
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
17/123 • Number of events 22
|
16.5%
18/109 • Number of events 26
|
16.8%
23/137 • Number of events 24
|
12.9%
4/31 • Number of events 5
|
|
Gastrointestinal disorders
Anal exam abnormal
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Blood disorder
|
6.5%
8/123 • Number of events 22
|
4.6%
5/109 • Number of events 21
|
5.8%
8/137 • Number of events 26
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.4%
14/123 • Number of events 17
|
11.9%
13/109 • Number of events 13
|
13.1%
18/137 • Number of events 18
|
16.1%
5/31 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
74.8%
92/123 • Number of events 398
|
82.6%
90/109 • Number of events 436
|
84.7%
116/137 • Number of events 516
|
74.2%
23/31 • Number of events 91
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
0.00%
0/137
|
6.5%
2/31 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.9%
6/123 • Number of events 16
|
0.00%
0/109
|
1.5%
2/137 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Arrhythmia
|
3.3%
4/123 • Number of events 4
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Conduction disorder
|
0.81%
1/123 • Number of events 4
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Edema
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Cardiac disorders
Myocardial ischemia
|
1.6%
2/123 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Cardiac disorders
Palpitations
|
0.81%
1/123 • Number of events 1
|
3.7%
4/109 • Number of events 4
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Premature ventricular contractions
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/123
|
3.7%
4/109 • Number of events 8
|
1.5%
2/137 • Number of events 6
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
4/123 • Number of events 5
|
8.3%
9/109 • Number of events 9
|
2.2%
3/137 • Number of events 4
|
6.5%
2/31 • Number of events 2
|
|
Cardiac disorders
Ventricular bigeminy
|
0.81%
1/123 • Number of events 2
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Ear disorder
|
1.6%
2/123 • Number of events 3
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Ear pain
|
0.81%
1/123 • Number of events 1
|
3.7%
4/109 • Number of events 5
|
2.2%
3/137 • Number of events 8
|
3.2%
1/31 • Number of events 1
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Colitis
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
28.5%
35/123 • Number of events 90
|
43.1%
47/109 • Number of events 123
|
33.6%
46/137 • Number of events 89
|
32.3%
10/31 • Number of events 23
|
|
Gastrointestinal disorders
Diarrhea
|
24.4%
30/123 • Number of events 47
|
32.1%
35/109 • Number of events 88
|
28.5%
39/137 • Number of events 60
|
19.4%
6/31 • Number of events 15
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
4/123 • Number of events 6
|
3.7%
4/109 • Number of events 10
|
0.73%
1/137 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
6/123 • Number of events 17
|
13.8%
15/109 • Number of events 24
|
7.3%
10/137 • Number of events 24
|
6.5%
2/31 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
2/123 • Number of events 9
|
0.92%
1/109 • Number of events 1
|
3.6%
5/137 • Number of events 6
|
0.00%
0/31
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.81%
1/123 • Number of events 2
|
5.5%
6/109 • Number of events 17
|
2.9%
4/137 • Number of events 5
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Flatulence
|
0.81%
1/123 • Number of events 2
|
2.8%
3/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
2/123 • Number of events 3
|
1.8%
2/109 • Number of events 2
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
4.9%
6/123 • Number of events 6
|
2.8%
3/109 • Number of events 3
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
4/123 • Number of events 15
|
2.8%
3/109 • Number of events 4
|
2.9%
4/137 • Number of events 8
|
0.00%
0/31
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Mucositis oral
|
6.5%
8/123 • Number of events 11
|
5.5%
6/109 • Number of events 10
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Nausea
|
52.0%
64/123 • Number of events 158
|
52.3%
57/109 • Number of events 155
|
57.7%
79/137 • Number of events 197
|
71.0%
22/31 • Number of events 50
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.73%
1/137 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Peritoneal pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Proctitis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.81%
1/123 • Number of events 2
|
0.00%
0/109
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 9
|
0.00%
0/31
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Stomach pain
|
1.6%
2/123 • Number of events 2
|
2.8%
3/109 • Number of events 10
|
0.73%
1/137 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Tooth disorder
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Toothache
|
2.4%
3/123 • Number of events 5
|
2.8%
3/109 • Number of events 6
|
2.2%
3/137 • Number of events 4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
18.7%
23/123 • Number of events 41
|
15.6%
17/109 • Number of events 31
|
34.3%
47/137 • Number of events 74
|
16.1%
5/31 • Number of events 9
|
|
General disorders
Chest pain
|
10.6%
13/123 • Number of events 14
|
11.9%
13/109 • Number of events 19
|
15.3%
21/137 • Number of events 30
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Chills
|
31.7%
39/123 • Number of events 50
|
35.8%
39/109 • Number of events 57
|
32.1%
44/137 • Number of events 61
|
16.1%
5/31 • Number of events 6
|
|
General disorders
Edema limbs
|
12.2%
15/123 • Number of events 31
|
18.3%
20/109 • Number of events 41
|
14.6%
20/137 • Number of events 49
|
9.7%
3/31 • Number of events 10
|
|
General disorders
Facial pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
General disorders
Fatigue
|
72.4%
89/123 • Number of events 401
|
82.6%
90/109 • Number of events 481
|
77.4%
106/137 • Number of events 408
|
77.4%
24/31 • Number of events 119
|
|
General disorders
Fever
|
15.4%
19/123 • Number of events 20
|
21.1%
23/109 • Number of events 27
|
16.8%
23/137 • Number of events 29
|
22.6%
7/31 • Number of events 8
|
|
General disorders
Flu-like symptoms
|
0.00%
0/123
|
5.5%
6/109 • Number of events 10
|
2.9%
4/137 • Number of events 5
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Gait abnormal
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
General symptom
|
2.4%
3/123 • Number of events 3
|
0.92%
1/109 • Number of events 1
|
2.2%
3/137 • Number of events 6
|
0.00%
0/31
|
|
General disorders
Injection site reaction
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Irritability
|
0.00%
0/123
|
0.92%
1/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
3.2%
1/31 • Number of events 4
|
|
General disorders
Localized edema
|
2.4%
3/123 • Number of events 3
|
3.7%
4/109 • Number of events 4
|
7.3%
10/137 • Number of events 14
|
3.2%
1/31 • Number of events 2
|
|
General disorders
Pain
|
9.8%
12/123 • Number of events 16
|
16.5%
18/109 • Number of events 38
|
13.9%
19/137 • Number of events 26
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Pericardial pain
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
2/123 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 3
|
0.00%
0/31
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Immune system disorders
Autoimmune disorder
|
1.6%
2/123 • Number of events 4
|
0.00%
0/109
|
1.5%
2/137 • Number of events 4
|
0.00%
0/31
|
|
Immune system disorders
Cytokine release syndrome
|
4.9%
6/123 • Number of events 6
|
4.6%
5/109 • Number of events 5
|
2.2%
3/137 • Number of events 3
|
3.2%
1/31 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
5.7%
7/123 • Number of events 7
|
10.1%
11/109 • Number of events 16
|
8.0%
11/137 • Number of events 13
|
6.5%
2/31 • Number of events 2
|
|
Immune system disorders
Immune system disorder
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Appendicitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Bladder infection
|
2.4%
3/123 • Number of events 3
|
1.8%
2/109 • Number of events 2
|
1.5%
2/137 • Number of events 3
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Bone infection
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Infections and infestations
Bronchitis
|
7.3%
9/123 • Number of events 11
|
10.1%
11/109 • Number of events 13
|
3.6%
5/137 • Number of events 7
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.4%
3/123 • Number of events 5
|
0.00%
0/109
|
2.9%
4/137 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Conjunctivitis infective
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Corneal infection
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Eye infection
|
0.00%
0/123
|
2.8%
3/109 • Number of events 4
|
0.73%
1/137 • Number of events 5
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Eye infection intraocular
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Gastric infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Gingival infection
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Infections and infestations
Hepatic infection
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Infection
|
5.7%
7/123 • Number of events 16
|
8.3%
9/109 • Number of events 12
|
2.9%
4/137 • Number of events 5
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Infectious meningitis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Joint infection
|
0.00%
0/123
|
0.00%
0/109
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Lip infection
|
1.6%
2/123 • Number of events 3
|
3.7%
4/109 • Number of events 5
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Nail infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 5
|
1.5%
2/137 • Number of events 4
|
0.00%
0/31
|
|
Infections and infestations
Opportunistic infection
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 2
|
2.2%
3/137 • Number of events 10
|
0.00%
0/31
|
|
Infections and infestations
Otitis externa
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Otitis media
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Penile infection
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Infections and infestations
Peripheral nerve infection
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Pharyngitis
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
6.5%
8/123 • Number of events 10
|
7.3%
8/109 • Number of events 9
|
3.6%
5/137 • Number of events 5
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Rhinitis infective
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Sepsis
|
1.6%
2/123 • Number of events 2
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Sinusitis
|
10.6%
13/123 • Number of events 18
|
11.0%
12/109 • Number of events 24
|
5.8%
8/137 • Number of events 11
|
0.00%
0/31
|
|
Infections and infestations
Skin infection
|
6.5%
8/123 • Number of events 9
|
6.4%
7/109 • Number of events 10
|
5.8%
8/137 • Number of events 10
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Soft tissue infection
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Tooth infection
|
2.4%
3/123 • Number of events 3
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Tracheitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Upper aerodigestive tract infection
|
1.6%
2/123 • Number of events 2
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Upper respiratory infection
|
12.2%
15/123 • Number of events 20
|
11.9%
13/109 • Number of events 21
|
8.8%
12/137 • Number of events 14
|
6.5%
2/31 • Number of events 3
|
|
Infections and infestations
Ureteritis
|
8.1%
10/123 • Number of events 13
|
7.3%
8/109 • Number of events 9
|
6.6%
9/137 • Number of events 13
|
3.2%
1/31 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.4%
3/123 • Number of events 5
|
5.5%
6/109 • Number of events 8
|
6.6%
9/137 • Number of events 12
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Vaginal infection
|
0.81%
1/123 • Number of events 1
|
3.7%
4/109 • Number of events 4
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Vulvitis
|
0.81%
1/123 • Number of events 3
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Infections and infestations
Wound infection
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Bruising
|
0.81%
1/123 • Number of events 1
|
5.5%
6/109 • Number of events 20
|
4.4%
6/137 • Number of events 6
|
3.2%
1/31 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
3/123 • Number of events 3
|
2.8%
3/109 • Number of events 7
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury - NERVES: Sciatic
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 3
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Venous injury - Extremity-upper
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 4
|
0.00%
0/137
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 4
|
0.73%
1/137 • Number of events 4
|
0.00%
0/31
|
|
Investigations
Alanine aminotransferase increased
|
22.8%
28/123 • Number of events 74
|
26.6%
29/109 • Number of events 89
|
24.1%
33/137 • Number of events 89
|
22.6%
7/31 • Number of events 19
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
19/123 • Number of events 39
|
13.8%
15/109 • Number of events 42
|
16.8%
23/137 • Number of events 50
|
12.9%
4/31 • Number of events 4
|
|
Investigations
Amylase increased
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Aspartate aminotransferase increased
|
25.2%
31/123 • Number of events 67
|
30.3%
33/109 • Number of events 76
|
24.1%
33/137 • Number of events 72
|
22.6%
7/31 • Number of events 13
|
|
Investigations
Blood bilirubin increased
|
19.5%
24/123 • Number of events 59
|
15.6%
17/109 • Number of events 49
|
6.6%
9/137 • Number of events 9
|
12.9%
4/31 • Number of events 19
|
|
Investigations
CD4 lymphocytes decreased
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
2.9%
4/137 • Number of events 7
|
3.2%
1/31 • Number of events 6
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Creatine phosphokinase increased
|
0.81%
1/123 • Number of events 2
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Creatinine increased
|
17.9%
22/123 • Number of events 34
|
16.5%
18/109 • Number of events 34
|
13.9%
19/137 • Number of events 39
|
6.5%
2/31 • Number of events 3
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 3
|
0.00%
0/31
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Haptoglobin decreased
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Investigations
INR increased
|
1.6%
2/123 • Number of events 4
|
1.8%
2/109 • Number of events 3
|
4.4%
6/137 • Number of events 18
|
0.00%
0/31
|
|
Investigations
Laboratory test abnormal
|
6.5%
8/123 • Number of events 22
|
7.3%
8/109 • Number of events 20
|
8.0%
11/137 • Number of events 30
|
9.7%
3/31 • Number of events 3
|
|
Investigations
Leukocyte count decreased
|
52.0%
64/123 • Number of events 258
|
56.0%
61/109 • Number of events 271
|
46.7%
64/137 • Number of events 273
|
45.2%
14/31 • Number of events 67
|
|
Investigations
Lipase increased
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Investigations
Lymphocyte count decreased
|
39.8%
49/123 • Number of events 225
|
44.0%
48/109 • Number of events 216
|
40.1%
55/137 • Number of events 281
|
32.3%
10/31 • Number of events 58
|
|
Investigations
Neutrophil count decreased
|
81.3%
100/123 • Number of events 356
|
89.0%
97/109 • Number of events 420
|
79.6%
109/137 • Number of events 370
|
90.3%
28/31 • Number of events 106
|
|
Investigations
Platelet count decreased
|
77.2%
95/123 • Number of events 528
|
78.0%
85/109 • Number of events 470
|
83.2%
114/137 • Number of events 546
|
71.0%
22/31 • Number of events 116
|
|
Investigations
Serum cholesterol increased
|
1.6%
2/123 • Number of events 2
|
1.8%
2/109 • Number of events 5
|
1.5%
2/137 • Number of events 7
|
0.00%
0/31
|
|
Investigations
Weight gain
|
10.6%
13/123 • Number of events 31
|
11.9%
13/109 • Number of events 21
|
8.8%
12/137 • Number of events 29
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Weight loss
|
4.1%
5/123 • Number of events 5
|
11.0%
12/109 • Number of events 15
|
7.3%
10/137 • Number of events 16
|
9.7%
3/31 • Number of events 3
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Anorexia
|
18.7%
23/123 • Number of events 41
|
25.7%
28/109 • Number of events 49
|
14.6%
20/137 • Number of events 26
|
22.6%
7/31 • Number of events 16
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
3.6%
5/137 • Number of events 6
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
43.9%
54/123 • Number of events 185
|
49.5%
54/109 • Number of events 217
|
45.3%
62/137 • Number of events 212
|
32.3%
10/31 • Number of events 39
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
5.7%
7/123 • Number of events 12
|
8.3%
9/109 • Number of events 22
|
7.3%
10/137 • Number of events 16
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
2/123 • Number of events 4
|
1.8%
2/109 • Number of events 6
|
1.5%
2/137 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.81%
1/123 • Number of events 3
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/123
|
0.00%
0/109
|
2.2%
3/137 • Number of events 11
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
12.2%
15/123 • Number of events 23
|
21.1%
23/109 • Number of events 43
|
14.6%
20/137 • Number of events 29
|
12.9%
4/31 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
25.2%
31/123 • Number of events 59
|
38.5%
42/109 • Number of events 78
|
27.7%
38/137 • Number of events 68
|
22.6%
7/31 • Number of events 20
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
3.3%
4/123 • Number of events 7
|
4.6%
5/109 • Number of events 10
|
1.5%
2/137 • Number of events 8
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.9%
6/123 • Number of events 14
|
4.6%
5/109 • Number of events 12
|
5.8%
8/137 • Number of events 10
|
3.2%
1/31 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.4%
3/123 • Number of events 5
|
5.5%
6/109 • Number of events 14
|
4.4%
6/137 • Number of events 7
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
9.8%
12/123 • Number of events 23
|
13.8%
15/109 • Number of events 36
|
5.8%
8/137 • Number of events 13
|
9.7%
3/31 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
13.0%
16/123 • Number of events 33
|
17.4%
19/109 • Number of events 35
|
16.1%
22/137 • Number of events 36
|
9.7%
3/31 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
8.9%
11/123 • Number of events 13
|
9.2%
10/109 • Number of events 14
|
8.8%
12/137 • Number of events 15
|
3.2%
1/31 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
17.1%
21/123 • Number of events 40
|
25.7%
28/109 • Number of events 46
|
16.8%
23/137 • Number of events 44
|
9.7%
3/31 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
5.7%
7/123 • Number of events 8
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 5
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
2.4%
3/123 • Number of events 3
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.5%
24/123 • Number of events 65
|
22.0%
24/109 • Number of events 57
|
17.5%
24/137 • Number of events 53
|
9.7%
3/31 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
2/123 • Number of events 5
|
2.8%
3/109 • Number of events 4
|
4.4%
6/137 • Number of events 13
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.9%
22/123 • Number of events 28
|
19.3%
21/109 • Number of events 57
|
16.8%
23/137 • Number of events 44
|
9.7%
3/31 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
7/123 • Number of events 11
|
6.4%
7/109 • Number of events 8
|
5.1%
7/137 • Number of events 11
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
2.9%
4/137 • Number of events 6
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.6%
2/123 • Number of events 3
|
0.00%
0/109
|
2.9%
4/137 • Number of events 6
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fibrosis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
2.4%
3/123 • Number of events 11
|
1.8%
2/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.9%
6/123 • Number of events 11
|
9.2%
10/109 • Number of events 12
|
2.2%
3/137 • Number of events 10
|
6.5%
2/31 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.81%
1/123 • Number of events 2
|
4.6%
5/109 • Number of events 11
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/123
|
4.6%
5/109 • Number of events 6
|
3.6%
5/137 • Number of events 7
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.8%
17/123 • Number of events 31
|
13.8%
15/109 • Number of events 43
|
11.7%
16/137 • Number of events 25
|
12.9%
4/31 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
7/123 • Number of events 9
|
4.6%
5/109 • Number of events 8
|
8.0%
11/137 • Number of events 20
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 3
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
17/123 • Number of events 34
|
16.5%
18/109 • Number of events 39
|
11.7%
16/137 • Number of events 33
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.4%
3/123 • Number of events 3
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
3.2%
1/31 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
4/123 • Number of events 4
|
7.3%
8/109 • Number of events 16
|
3.6%
5/137 • Number of events 8
|
0.00%
0/31
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Ataxia
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Cognitive disturbance
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
3.2%
1/31 • Number of events 5
|
|
Nervous system disorders
Depressed level of consciousness
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Dizziness
|
13.8%
17/123 • Number of events 33
|
22.9%
25/109 • Number of events 49
|
13.9%
19/137 • Number of events 32
|
6.5%
2/31 • Number of events 5
|
|
Nervous system disorders
Dysgeusia
|
7.3%
9/123 • Number of events 14
|
11.0%
12/109 • Number of events 19
|
3.6%
5/137 • Number of events 6
|
3.2%
1/31 • Number of events 4
|
|
Nervous system disorders
Encephalopathy
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 3
|
2.2%
3/137 • Number of events 3
|
3.2%
1/31 • Number of events 2
|
|
Nervous system disorders
Headache
|
26.8%
33/123 • Number of events 62
|
32.1%
35/109 • Number of events 72
|
19.7%
27/137 • Number of events 60
|
25.8%
8/31 • Number of events 22
|
|
Nervous system disorders
Memory impairment
|
2.4%
3/123 • Number of events 3
|
2.8%
3/109 • Number of events 22
|
3.6%
5/137 • Number of events 9
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Neurological disorder NOS
|
3.3%
4/123 • Number of events 6
|
4.6%
5/109 • Number of events 10
|
5.1%
7/137 • Number of events 12
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/123
|
1.8%
2/109 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.6%
18/123 • Number of events 39
|
18.3%
20/109 • Number of events 69
|
12.4%
17/137 • Number of events 56
|
6.5%
2/31 • Number of events 3
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Seizure
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Sinus pain
|
3.3%
4/123 • Number of events 4
|
2.8%
3/109 • Number of events 6
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Nervous system disorders
Speech disorder
|
1.6%
2/123 • Number of events 2
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Syncope
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
0.00%
0/137
|
0.00%
0/31
|
|
Nervous system disorders
Tremor
|
2.4%
3/123 • Number of events 4
|
2.8%
3/109 • Number of events 4
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/123
|
2.8%
3/109 • Number of events 10
|
2.2%
3/137 • Number of events 4
|
0.00%
0/31
|
|
Psychiatric disorders
Anxiety
|
11.4%
14/123 • Number of events 38
|
15.6%
17/109 • Number of events 27
|
9.5%
13/137 • Number of events 22
|
6.5%
2/31 • Number of events 4
|
|
Psychiatric disorders
Confusion
|
0.81%
1/123 • Number of events 2
|
1.8%
2/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Psychiatric disorders
Depression
|
6.5%
8/123 • Number of events 35
|
10.1%
11/109 • Number of events 23
|
6.6%
9/137 • Number of events 16
|
6.5%
2/31 • Number of events 18
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/123
|
1.8%
2/109 • Number of events 8
|
0.00%
0/137
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
15.4%
19/123 • Number of events 45
|
21.1%
23/109 • Number of events 52
|
18.2%
25/137 • Number of events 55
|
16.1%
5/31 • Number of events 12
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 6
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/123
|
1.8%
2/109 • Number of events 5
|
2.2%
3/137 • Number of events 3
|
0.00%
0/31
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
2.9%
4/137 • Number of events 7
|
0.00%
0/31
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.81%
1/123 • Number of events 1
|
4.6%
5/109 • Number of events 10
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Renal and urinary disorders
Kidney pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Renal and urinary disorders
Proteinuria
|
0.81%
1/123 • Number of events 1
|
5.5%
6/109 • Number of events 7
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary frequency
|
4.9%
6/123 • Number of events 15
|
8.3%
9/109 • Number of events 17
|
8.8%
12/137 • Number of events 21
|
6.5%
2/31 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/123
|
2.8%
3/109 • Number of events 3
|
2.9%
4/137 • Number of events 16
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
3/123 • Number of events 4
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/123
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
4.1%
5/123 • Number of events 9
|
3.7%
4/109 • Number of events 10
|
3.6%
5/137 • Number of events 15
|
6.5%
2/31 • Number of events 3
|
|
Reproductive system and breast disorders
Breast pain
|
1.6%
2/123 • Number of events 2
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/123
|
1.8%
2/109 • Number of events 7
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.81%
1/123 • Number of events 2
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.6%
18/123 • Number of events 48
|
16.5%
18/109 • Number of events 42
|
9.5%
13/137 • Number of events 24
|
3.2%
1/31 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.6%
2/123 • Number of events 2
|
0.00%
0/109
|
2.2%
3/137 • Number of events 7
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
30/123 • Number of events 69
|
44.0%
48/109 • Number of events 122
|
32.1%
44/137 • Number of events 91
|
25.8%
8/31 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.0%
32/123 • Number of events 102
|
39.4%
43/109 • Number of events 104
|
31.4%
43/137 • Number of events 90
|
29.0%
9/31 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
2/123 • Number of events 2
|
2.8%
3/109 • Number of events 8
|
2.9%
4/137 • Number of events 7
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.81%
1/123 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
2.9%
4/137 • Number of events 6
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.7%
7/123 • Number of events 9
|
1.8%
2/109 • Number of events 2
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.7%
7/123 • Number of events 14
|
7.3%
8/109 • Number of events 19
|
9.5%
13/137 • Number of events 16
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
2.9%
4/137 • Number of events 4
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.1%
5/123 • Number of events 6
|
5.5%
6/109 • Number of events 10
|
0.73%
1/137 • Number of events 4
|
6.5%
2/31 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.81%
1/123 • Number of events 1
|
2.8%
3/109 • Number of events 5
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
4/123 • Number of events 9
|
3.7%
4/109 • Number of events 16
|
2.2%
3/137 • Number of events 5
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/123
|
0.00%
0/109
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
4/123 • Number of events 5
|
9.2%
10/109 • Number of events 21
|
4.4%
6/137 • Number of events 21
|
6.5%
2/31 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.81%
1/123 • Number of events 5
|
1.8%
2/109 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.4%
3/123 • Number of events 3
|
0.00%
0/109
|
1.5%
2/137 • Number of events 3
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.4%
14/123 • Number of events 24
|
18.3%
20/109 • Number of events 35
|
13.1%
18/137 • Number of events 25
|
22.6%
7/31 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
26.0%
32/123 • Number of events 48
|
45.0%
49/109 • Number of events 122
|
36.5%
50/137 • Number of events 99
|
48.4%
15/31 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/123
|
1.8%
2/109 • Number of events 2
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.4%
3/123 • Number of events 3
|
9.2%
10/109 • Number of events 11
|
6.6%
9/137 • Number of events 14
|
12.9%
4/31 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/123
|
0.00%
0/109
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/123
|
0.92%
1/109 • Number of events 4
|
0.00%
0/137
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.4%
3/123 • Number of events 4
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
17.1%
21/123 • Number of events 52
|
24.8%
27/109 • Number of events 50
|
22.6%
31/137 • Number of events 81
|
19.4%
6/31 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
4/123 • Number of events 9
|
3.7%
4/109 • Number of events 7
|
4.4%
6/137 • Number of events 8
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Flushing
|
3.3%
4/123 • Number of events 9
|
6.4%
7/109 • Number of events 17
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Vascular disorders
Hematoma
|
0.81%
1/123 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/123
|
3.7%
4/109 • Number of events 9
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Hot flashes
|
4.1%
5/123 • Number of events 9
|
2.8%
3/109 • Number of events 10
|
4.4%
6/137 • Number of events 14
|
6.5%
2/31 • Number of events 6
|
|
Vascular disorders
Hypertension
|
13.0%
16/123 • Number of events 27
|
16.5%
18/109 • Number of events 76
|
14.6%
20/137 • Number of events 55
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Hypotension
|
12.2%
15/123 • Number of events 24
|
11.0%
12/109 • Number of events 13
|
14.6%
20/137 • Number of events 30
|
6.5%
2/31 • Number of events 2
|
|
Vascular disorders
Lymphedema
|
0.00%
0/123
|
0.92%
1/109 • Number of events 1
|
0.00%
0/137
|
0.00%
0/31
|
|
Vascular disorders
Lymphocele
|
0.00%
0/123
|
0.00%
0/109
|
0.73%
1/137 • Number of events 2
|
0.00%
0/31
|
|
Vascular disorders
Phlebitis
|
4.1%
5/123 • Number of events 6
|
0.92%
1/109 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Thrombosis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
1.5%
2/137 • Number of events 2
|
0.00%
0/31
|
|
Vascular disorders
Vascular disorder
|
0.81%
1/123 • Number of events 1
|
0.00%
0/109
|
0.00%
0/137
|
0.00%
0/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60