Trial Outcomes & Findings for Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger (NCT NCT00290498)
NCT ID: NCT00290498
Last Updated: 2020-06-02
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
3 years
Results posted on
2020-06-02
Participant Flow
Patient eligibility:\>/16 -\</60 years old and untreated Diffuse Large B-cell Lymphoma,stage II \>/10cm mass or stage III/IV),Eastern Cooperative Oncology Group 0-2,age-adjusted Integrated Pulmonary Index of .2, and adequate organ function. Excluded:if they were pregnant,breast-feeding,or evidenced central nervous system lymphoma or active infections.
Three participants were screen failures. Eight participants were removed
Participant milestones
| Measure |
R-HCVAD-MA
I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg \& vincristine 1.4mg - 2mg, \& oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg \& 800mg 22h, \& cytarabine 3g.
|
R-CHOP
R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
10
|
|
Overall Study
COMPLETED
|
41
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
R-HCVAD-MA
I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg \& vincristine 1.4mg - 2mg, \& oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg \& 800mg 22h, \& cytarabine 3g.
|
R-CHOP
R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Ineligible
|
3
|
0
|
|
Overall Study
Non-Compliance
|
1
|
0
|
Baseline Characteristics
Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger
Baseline characteristics by cohort
| Measure |
R-HCVAD/R-MA
n=49 Participants
I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg \& vincristine 1.4mg - 2mg, \& oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg \& 800mg 22h, \& cytarabine 3g.
|
R-CHOP
n=10 Participants
R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11 • n=5 Participants
|
39 years
STANDARD_DEVIATION 11 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
R-HCVAD
n=49 Participants
I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg \& vincristine 1.4mg - 2mg, \& oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg \& 800mg 22h, \& cytarabine 3g.
|
R-CHOP
n=10 Participants
R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
|
|---|---|---|
|
Response Rate R-HCVAD vs. R-CHOP
Complete Remission
|
40 Participants
|
7 Participants
|
|
Response Rate R-HCVAD vs. R-CHOP
Inevaluable
|
2 Participants
|
1 Participants
|
|
Response Rate R-HCVAD vs. R-CHOP
Progressive Disease
|
1 Participants
|
1 Participants
|
|
Response Rate R-HCVAD vs. R-CHOP
Partial Remission
|
4 Participants
|
0 Participants
|
|
Response Rate R-HCVAD vs. R-CHOP
Complete Remission Unconfirmed
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 years post-therapyProgression free survival (PFS) for three years following therapy with Rituxan-HCVAD alternating with Rituximab with high -dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features.
Outcome measures
| Measure |
R-HCVAD
n=49 Participants
I.V. rituximab 375mg, cyclophosphamide 300mg, doxorubicin 50mg \& vincristine 1.4mg - 2mg, \& oral dexamethasone 40mg. Alternate R-MA: IV rituximab 375mg, methotrexate 200mg \& 800mg 22h, \& cytarabine 3g.
|
R-CHOP
n=10 Participants
R-CHOP: Day 1 I.V. rituximab 375mg, cyclophosphamide 750mg, doxorubicin 50mg, vincristine 1.4mg max 2mg, and oral prednisone 100mg orally.
|
|---|---|---|
|
Progression Free Survival (Rate)
|
35 Participants
|
7 Participants
|
Adverse Events
RHCVAD
Serious events: 49 serious events
Other events: 46 other events
Deaths: 4 deaths
RCHOP
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RHCVAD
n=49 participants at risk
Rituximab 375mg/m2 intravenously on day 1,cyclophosphamide 300mg/m2 intravenously every 12 h for six doses on days 13,doxorubicin 50mg/m2 intravenously on day 5,vincristine 1.4mg/m2 or maximum 2mg intravenously on days 5 and 12,and dexamethasone 40mg intravenously or orally on days 25,alternating with RMA(cycles 2,4,6,)rituximab 375mg/2 intravenously on day 1,methotrexate 200mg/m2 over 2 h followed by 800mg/m2 over 22 h on day 1, and cytarabine 3g/m2 every 12 h for four doses on days 3 and 4, with a 21 day cycle.
|
RCHOP
n=10 participants at risk
RCHOP consisted of rituximab 375mg/m2 intravenously on day 1,cyclophosphamide 750mg/m2 intravenously on day 1,doxorubicin 50mg/m2 intravenously on day 1 either over 15min or 48 h , vincristine 1.4mg/m2 or maximum 2mg intravenously,and prednisone 100mg orally on days 15,with a 21d cycle.
|
|---|---|---|
|
Gastrointestinal disorders
PAIN( ORALCAVITY)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN (CHEST/THORAX)
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
PAIN (DENTAL/TEETH/PERID
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (EXTREMITY-LIMB)
|
12.2%
6/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Eye disorders
PAIN (EYE)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
PAIN( HEAD/HEADACHE)
|
44.9%
22/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (JOINT)
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (MUSCLE)
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (NECK)
|
10.2%
5/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
PAIN (NEURALGIA/PERIPHERALNER
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
PAIN (NOS)
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Reproductive system and breast disorders
PAIN (TESTICLE)
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN (THROAT/PHARYNX/LARYNX)
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Reproductive system and breast disorders
PAIN (VAGINA)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
PALPITATIONS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Blood and lymphatic system disorders
PETECHIAE
|
12.2%
6/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Blood and lymphatic system disorders
PHLEBITIS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
PLATELETS DECREASED
|
79.6%
39/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
16.3%
8/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Renal and urinary disorders
POLYURIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (PELVIS)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN (PLEURITIC)
|
0.00%
0/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
PAIN( STOMACH)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Psychiatric disorders
CONFUSION
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
32.7%
16/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
34.7%
17/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
CREATININE INCREASE
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
DEATH NOS
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
DIABETES
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
DIARRHEA
|
22.4%
11/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
DISTENSION/BLOATING
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
DIZZINESS
|
28.6%
14/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
DRUG FEVER
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Eye disorders
DRY EYE
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
44.9%
22/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Renal and urinary disorders
DYSURIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
EDEMA
|
16.3%
8/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
EDEMA:HEAD AND NECK
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
EDEMA:LIMB
|
26.5%
13/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
EDEMA:TRUNK/GENITAL
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
EDEMA (LARYNX)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
ELEV LDH (OTHER)
|
12.2%
6/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Endocrine disorders
ENDOCRINE (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
10.2%
5/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
FATIGUE
|
63.3%
31/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
55.1%
27/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
FEVER UNKNOWN ORIGIN
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
FEVER WITHOUT NEUTROPENI
|
28.6%
14/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
FLU-LIKE SYNDROME
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Vascular disorders
FLUSHING
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
GAIT/WALKING
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
GASTRITIS
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
GERD
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL (OTHER)
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
GRANULOCYTOPENIA
|
0.00%
0/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
HAND-FOOT SYNDROME
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
HEADACHE
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
HEARTBURN
|
10.2%
5/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Vascular disorders
HEMATOMA
|
0.00%
0/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Renal and urinary disorders
HEMATURIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HEMOGLOBIN DECREASE
|
98.0%
48/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
70.0%
7/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Blood and lymphatic system disorders
HEMORRHAGE
|
16.3%
8/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
12.2%
6/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HORSENESS
|
0.00%
0/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Reproductive system and breast disorders
HOT FLASHES
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPERGLYCEMIA
|
51.0%
25/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
60.0%
6/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPERKALEMIA
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
HYPERTENSION
|
18.4%
9/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Endocrine disorders
HYPERTHYROIDISM
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPERURICEMIA
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
50.0%
5/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPOALBUMINEMIA
|
55.1%
27/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPOCALCEMIA
|
30.6%
15/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPOGLYCEMIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPOKALEMIA
|
30.6%
15/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPOMAGNESEMIA
|
28.6%
14/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
60.0%
6/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPONATREMIA
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
HYPOPHOSPHATEMIA
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
HYPOTENSION
|
26.5%
13/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Endocrine disorders
HYPOTHYROIDISM
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Infections and infestations
INFECTION(S)
|
95.9%
47/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
60.0%
6/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Psychiatric disorders
INSOMNIA
|
24.5%
12/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
LEUKOPENIA
|
98.0%
48/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
70.0%
7/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Psychiatric disorders
MOOD ALTERATION
|
32.7%
16/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
MUCOSITIS
|
40.8%
20/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
16.3%
8/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
61.2%
30/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
60.0%
6/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
NEUROPATHY:MOTOR
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
NEUROPATHY:SENSORY
|
40.8%
20/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
NEUTROPENIA
|
93.9%
46/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
OBESITY
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
OBSTRUCTION,GI
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Eye disorders
OCULAR/VISUAL(OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
OLIGURIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
PAIN (ABDOMEN NOS)
|
12.2%
6/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
PAIN (ANUS)
|
0.00%
0/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (BACK)
|
20.4%
10/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN (BONE)
|
10.2%
5/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Reproductive system and breast disorders
PAIN (BREAST)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
ABDOMINAL CRAMPING
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
ALKALINE PHOSPHATASE INCR
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Immune system disorders
ALLERGIC REACTION DRUG
|
20.4%
10/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
18.4%
9/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Immune system disorders
ALLERGY (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
40.8%
20/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
50.0%
5/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
ALT,SGPT INCR
|
34.7%
17/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
AST,SGOT INCR
|
34.7%
17/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Ear and labyrinth disorders
AUDITORY/EAR (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Immune system disorders
AUTOIMMUNE REACTION
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
BILIRUBIN INCREASE
|
18.4%
9/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Eye disorders
BLURRED VISION
|
0.00%
0/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Blood and lymphatic system disorders
BLOOD BONE MARROW (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Injury, poisoning and procedural complications
BRUISING (NON-THROMBOPENIA)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Infections and infestations
CANDIDIASIS
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
CHOLESTEROL,SERUM-HIGH
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY(OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
PULMONARY EMBOLISM
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
28.6%
14/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
12.2%
6/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
General disorders
RIGORS/CHILLS
|
36.7%
18/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
SENSORY
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
18.4%
9/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
STOMATITIS
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Vascular disorders
SYNDROMES (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Cardiac disorders
TACHYCARDIA
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
TASTE ALTERATION
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
TEETH
|
4.1%
2/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Investigations
THROMBOCYTOPENIA
|
14.3%
7/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
24.5%
12/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Ear and labyrinth disorders
TINNITUS
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
ULCERATION
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECT
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Vascular disorders
VASCULAR (OTHER)
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES
|
6.1%
3/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Gastrointestinal disorders
VOMITING
|
49.0%
24/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
50.0%
5/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Eye disorders
WATERY EYE
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
WEIGHT GAIN
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
2.0%
1/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
Other adverse events
| Measure |
RHCVAD
n=49 participants at risk
Rituximab 375mg/m2 intravenously on day 1,cyclophosphamide 300mg/m2 intravenously every 12 h for six doses on days 13,doxorubicin 50mg/m2 intravenously on day 5,vincristine 1.4mg/m2 or maximum 2mg intravenously on days 5 and 12,and dexamethasone 40mg intravenously or orally on days 25,alternating with RMA(cycles 2,4,6,)rituximab 375mg/2 intravenously on day 1,methotrexate 200mg/m2 over 2 h followed by 800mg/m2 over 22 h on day 1, and cytarabine 3g/m2 every 12 h for four doses on days 3 and 4, with a 21 day cycle.
|
RCHOP
n=10 participants at risk
RCHOP consisted of rituximab 375mg/m2 intravenously on day 1,cyclophosphamide 750mg/m2 intravenously on day 1,doxorubicin 50mg/m2 intravenously on day 1 either over 15min or 48 h , vincristine 1.4mg/m2 or maximum 2mg intravenously,and prednisone 100mg orally on days 15,with a 21d cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
93.9%
46/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
40.0%
4/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Blood and lymphatic system disorders
Platelets
|
79.6%
39/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
30.0%
3/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Infections and infestations
Febrile Neutropenia
|
51.0%
25/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
20.0%
2/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Infections and infestations
Infection
|
67.3%
33/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
50.0%
5/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Vascular disorders
Thrombosis/Embolism
|
24.5%
12/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
10.0%
1/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
|
Renal and urinary disorders
Renal Failure
|
8.2%
4/49 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
0.00%
0/10 • From the initiation of the regimen until the end of chemotherapy, an average of 3 years
|
Additional Information
Dr. Luis E. Fayad / Lymphoma/Myeloma
U.T. MD Anderson Cancer Center
Phone: 7137922860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place