Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma (NCT NCT00878254)
NCT ID: NCT00878254
Last Updated: 2025-07-23
Results Overview
Progression-Free Survival (PFS) among study participants. PFS is defined as the time in years from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 12 years
Results posted on
2025-07-23
Participant Flow
Participant milestones
| Measure |
R-MACLO/IVAM Group
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
R-MACLO/IVAM Group
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
R-MACLO/IVAM Group
n=25 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 yearsPopulation: Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy.
Progression-Free Survival (PFS) among study participants. PFS is defined as the time in years from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans.
Outcome measures
| Measure |
R-MACLO/IVAM Group
n=22 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Progression-Free Survival (PFS)
|
8 years
Interval 3.4 to 11.0
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy.
Progression-Free Survival (PFS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of participants alive without relapse or disease progression at 5 years after starting study therapy. PFS is defined as the time from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans.
Outcome measures
| Measure |
R-MACLO/IVAM Group
n=22 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Progression-Free Survival (PFS) Rate at 5 Years Using Kaplan-Meier Method
|
57.1 percentage probability at 5 years
Interval 31.3 to 76.3
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy.
Overall Survival (OS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of survival beyond 5 years. OS is defined as elapsed time from start date of treatment to date of death from any cause. Alive participants will be censored at last date known to be alive.
Outcome measures
| Measure |
R-MACLO/IVAM Group
n=22 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Overall Survival (OS) Rate at 5 Years Using Kaplan-Meier Method
|
79.7 percentage probability at 5 years
Interval 54.2 to 91.9
|
SECONDARY outcome
Timeframe: Up to 8 yearsPopulation: Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy and evaluated for response.
The rate of response to study therapy will be reported as the number of participants achieving complete response (CR), complete response/unconfirmed (CRu) or partial response (PR) to protocol therapy according to criteria assignable to Non-Hodgkin's Lymphoma (NHL). Response assessment will be done by CT and Positron emission tomography (PET) scans, and bone marrow biopsy/aspirate, if clinically indicated.
Outcome measures
| Measure |
R-MACLO/IVAM Group
n=22 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Rate of Response to Study Therapy
Complete Response (CR)
|
20 Participants
|
|
Rate of Response to Study Therapy
Complete Response unconfirmed (CRu)
|
0 Participants
|
|
Rate of Response to Study Therapy
Partial Response (PR)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsThe number of participants experiencing treatment-related serious adverse events (SAEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician.
Outcome measures
| Measure |
R-MACLO/IVAM Group
n=25 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Number of Participants Experiencing Treatment-Related Serious Adverse Events During R-MACLO/IVAM Induction Therapy
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsThe number of participants experiencing treatment-related adverse events (AEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician.
Outcome measures
| Measure |
R-MACLO/IVAM Group
n=25 Participants
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Number of Participants Experiencing Treatment-Related Adverse Events During R-MACLO/IVAM Induction Therapy
Grade 1 and 2 AEs
|
25 Participants
|
|
Number of Participants Experiencing Treatment-Related Adverse Events During R-MACLO/IVAM Induction Therapy
Grade 3 or higher AEs
|
24 Participants
|
Adverse Events
R-MACLO/IVAM Group
Serious events: 8 serious events
Other events: 25 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
R-MACLO/IVAM Group
n=25 participants at risk
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Blood and lymphatic system disorders
Chemo induced myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML)
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Metabolism and nutrition disorders
Creatinine increased
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Febrile neutropenia
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Sepsis
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Infections and infestations
Infection, Lung (pneumonia)
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Infections and infestations
Joint Infection
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
1/25 • Number of events 1 • 12 years
|
Other adverse events
| Measure |
R-MACLO/IVAM Group
n=25 participants at risk
Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows:
Induction Therapy:
* Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin and Granulocyte-colony stimulating factor (G-CSF)
* Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF.
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years.
Total participation duration is about 4 years. Participants will be followed for survival.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
General disorders
Abdominal pain
|
24.0%
6/25 • Number of events 9 • 12 years
|
|
Nervous system disorders
Agitation
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
60.0%
15/25 • Number of events 51 • 12 years
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
40.0%
10/25 • Number of events 27 • 12 years
|
|
Immune system disorders
Allergic reaction
|
32.0%
8/25 • Number of events 9 • 12 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.0%
6/25 • Number of events 15 • 12 years
|
|
Gastrointestinal disorders
Anorexia
|
24.0%
6/25 • Number of events 7 • 12 years
|
|
Nervous system disorders
Anxiety
|
24.0%
6/25 • Number of events 13 • 12 years
|
|
Infections and infestations
Appendicitis
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Appendicitis perforated
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Number of events 4 • 12 years
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
44.0%
11/25 • Number of events 35 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
1/25 • Number of events 9 • 12 years
|
|
Immune system disorders
Autoimmune reaction
|
8.0%
2/25 • Number of events 4 • 12 years
|
|
General disorders
Back pain
|
12.0%
3/25 • Number of events 3 • 12 years
|
|
Infections and infestations
Bladder infection
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Blood - Other
|
24.0%
6/25 • Number of events 53 • 12 years
|
|
Eye disorders
Blurred vision
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Bone pain
|
28.0%
7/25 • Number of events 10 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Chest pain
|
12.0%
3/25 • Number of events 5 • 12 years
|
|
General disorders
Chest wall pain
|
12.0%
3/25 • Number of events 4 • 12 years
|
|
Nervous system disorders
Confusion
|
16.0%
4/25 • Number of events 4 • 12 years
|
|
Gastrointestinal disorders
Constipation
|
64.0%
16/25 • Number of events 31 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.0%
7/25 • Number of events 10 • 12 years
|
|
Metabolism and nutrition disorders
Creatine phosphokinase increased
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Metabolism and nutrition disorders
Creatinine increased
|
40.0%
10/25 • Number of events 45 • 12 years
|
|
Renal and urinary disorders
Cystitis
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Nervous system disorders
Depression
|
16.0%
4/25 • Number of events 4 • 12 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
24.0%
6/25 • Number of events 13 • 12 years
|
|
Gastrointestinal disorders
Diarrhea
|
68.0%
17/25 • Number of events 37 • 12 years
|
|
Nervous system disorders
Dizziness
|
32.0%
8/25 • Number of events 10 • 12 years
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
3/25 • Number of events 4 • 12 years
|
|
Gastrointestinal disorders
Dysphagia
|
16.0%
4/25 • Number of events 6 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.0%
8/25 • Number of events 21 • 12 years
|
|
Blood and lymphatic system disorders
Edema limbs
|
36.0%
9/25 • Number of events 25 • 12 years
|
|
Nervous system disorders
Encephalopathy
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Esophageal pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Esophageal ulcer
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Gastrointestinal disorders
Esophagitis
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Eye pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Fatigue
|
72.0%
18/25 • Number of events 61 • 12 years
|
|
Infections and infestations
Febrile neutropenia
|
56.0%
14/25 • Number of events 31 • 12 years
|
|
General disorders
Fever
|
60.0%
15/25 • Number of events 53 • 12 years
|
|
Gastrointestinal disorders
Flatulence
|
12.0%
3/25 • Number of events 3 • 12 years
|
|
Skin and subcutaneous tissue disorders
Flushing
|
8.0%
2/25 • Number of events 5 • 12 years
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
5/25 • Number of events 11 • 12 years
|
|
Metabolism and nutrition disorders
Glomerular filtration rate decreased
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
General disorders
Headache
|
64.0%
16/25 • Number of events 46 • 12 years
|
|
Gastrointestinal disorders
Heartburn
|
20.0%
5/25 • Number of events 6 • 12 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
96.0%
24/25 • Number of events 468 • 12 years
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
28.0%
7/25 • Number of events 40 • 12 years
|
|
Vascular disorders
Hemorrhage nasal
|
16.0%
4/25 • Number of events 11 • 12 years
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.0%
2/25 • Number of events 3 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
12.0%
3/25 • Number of events 6 • 12 years
|
|
Endocrine disorders
Hot flashes
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
44.0%
11/25 • Number of events 34 • 12 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.0%
4/25 • Number of events 8 • 12 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
80.0%
20/25 • Number of events 149 • 12 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.0%
2/25 • Number of events 3 • 12 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
24.0%
6/25 • Number of events 7 • 12 years
|
|
Cardiac disorders
Hypertension
|
16.0%
4/25 • Number of events 26 • 12 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.0%
3/25 • Number of events 3 • 12 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
96.0%
24/25 • Number of events 257 • 12 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
92.0%
23/25 • Number of events 202 • 12 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
5/25 • Number of events 13 • 12 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
88.0%
22/25 • Number of events 107 • 12 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
48.0%
12/25 • Number of events 38 • 12 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
15/25 • Number of events 45 • 12 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.0%
4/25 • Number of events 20 • 12 years
|
|
Cardiac disorders
Hypotension
|
24.0%
6/25 • Number of events 9 • 12 years
|
|
Infections and infestations
Infection - Other (Specify)
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Infection, Anal/perianal
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Infection, Lung (pneumonia)
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Infection, Mucosa
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Infection, Skin (cellulites)
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Infections and infestations
Infection, Urinary tract NOS
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
12.0%
3/25 • Number of events 4 • 12 years
|
|
General disorders
Insomnia
|
20.0%
5/25 • Number of events 7 • 12 years
|
|
Nervous system disorders
Involuntary movement
|
4.0%
1/25 • Number of events 3 • 12 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
16.0%
4/25 • Number of events 7 • 12 years
|
|
Blood and lymphatic system disorders
Leukocytes
|
100.0%
25/25 • Number of events 510 • 12 years
|
|
Nervous system disorders
Leukoencephalopathy
|
4.0%
1/25 • Number of events 3 • 12 years
|
|
Hepatobiliary disorders
Liver dysfunction
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Lymphedema-related fibrosis
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
88.0%
22/25 • Number of events 330 • 12 years
|
|
Gastrointestinal disorders
Mucositis
|
88.0%
22/25 • Number of events 56 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
20.0%
5/25 • Number of events 6 • 12 years
|
|
General disorders
Myalgia
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Gastrointestinal disorders
Nausea
|
80.0%
20/25 • Number of events 79 • 12 years
|
|
General disorders
Neck pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Neuralgia
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Nervous system disorders
Neurology - Other
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Neutrophils
|
100.0%
25/25 • Number of events 349 • 12 years
|
|
Nervous system disorders
Neuropathy: Sensory
|
32.0%
8/25 • Number of events 14 • 12 years
|
|
General disorders
Oral pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Vascular disorders
Petechiae
|
32.0%
8/25 • Number of events 10 • 12 years
|
|
Infections and infestations
Pharyngitis
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Pharyngolaryngeal pain
|
16.0%
4/25 • Number of events 4 • 12 years
|
|
Infections and infestations
Phlebitis infective
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Blood and lymphatic system disorders
Platelets
|
96.0%
24/25 • Number of events 472 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.0%
3/25 • Number of events 5 • 12 years
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.0%
2/25 • Number of events 4 • 12 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.0%
11/25 • Number of events 17 • 12 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
56.0%
14/25 • Number of events 35 • 12 years
|
|
General disorders
Rectal pain
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
General disorders
Rigors/chills
|
60.0%
15/25 • Number of events 24 • 12 years
|
|
Infections and infestations
Sepsis
|
24.0%
6/25 • Number of events 11 • 12 years
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Infections and infestations
Skin infection
|
12.0%
3/25 • Number of events 6 • 12 years
|
|
General disorders
Sweating
|
16.0%
4/25 • Number of events 6 • 12 years
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Tooth disorder
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Nervous system disorders
Tremor
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Renal and urinary disorders
Ureteric hemorrhage
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Renal and urinary disorders
Urinary frequency
|
12.0%
3/25 • Number of events 12 • 12 years
|
|
Renal and urinary disorders
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Vomiting
|
56.0%
14/25 • Number of events 43 • 12 years
|
|
General disorders
Weight loss
|
16.0%
4/25 • Number of events 5 • 12 years
|
|
Nervous system disorders
Metabolic/Lab - Other
|
36.0%
9/25 • Number of events 222 • 12 years
|
|
General disorders
Weight gain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Cardiac disorders
Ventricular tachycardia
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Infections and infestations
Upper respiratory infection
|
24.0%
6/25 • Number of events 8 • 12 years
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Immune system disorders
Rhinitis
|
28.0%
7/25 • Number of events 12 • 12 years
|
|
Eye disorders
Retinal detachment
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Rectal fistula
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other(specify)
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Metabolism and nutrition disorders
Proteinuria
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Phlebitis
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Nervous system disorders
Neuropathy: Motor
|
4.0%
1/25 • Number of events 12 • 12 years
|
|
Nervous system disorders
Neuropathy: Cranial
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Cardiac disorders
Palpitations
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Pain of skin
|
4.0%
1/25 • Number of events 4 • 12 years
|
|
General disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Ear and labyrinth disorders
Otitis, middle ear
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Oral hemorrhage
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Hematoma
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify)
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Eye disorders
Flashing vision
|
8.0%
2/25 • Number of events 2 • 12 years
|
|
Infections and infestations
Eye Infection
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
External ear pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Constitutional Symptoms - Other
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Cardiac disorders
Cardiac arrhymthia
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Buttock pain
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Blood and lymphatic system disorders
Blood - Other (Specify)
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Renal and urinary disorders
Bladder hemorrhage
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Cardiac disorders
Atrial tachycardia
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
Gastrointestinal disorders
Anal fistula
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Immune system disorders
Allergy - Other
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Infection - Other
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other (Specify)
|
8.0%
2/25 • Number of events 4 • 12 years
|
|
Skin and subcutaneous tissue disorders
Induration
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
Infections and infestations
Infection, Upper airway NOS
|
4.0%
1/25 • Number of events 2 • 12 years
|
|
General disorders
Kidney pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
|
General disorders
Lymph node pain
|
4.0%
1/25 • Number of events 1 • 12 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place