Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
Study Details
Study Description
Brief Summary
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
-
To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously untreated, but symptomatic, CLL.
-
To determine if alemtuzumab improves the CR rate with acceptable toxicity when administered as consolidation therapy following induction therapy with fludarabine and rituximab.
-
To estimate the progression-free and overall survival of high risk (VH gene unmutated and those with p53 dysfunction) and low-risk (others) patients following therapy with fludarabine and rituximab induction and consolidative alemtuzumab.
-
To determine the frequency of molecular (PCR) remission following fludarabine and rituximab induction therapy and alemtuzumab consolidation therapy and if this serves as a surrogate marker for prolonged progression-free and overall survival.
SECONDARY OBJECTIVES:
-
To determine the effect of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab on recovery of T-cells, NK cells, and serum immunoglobulin levels.
-
To determine clinical and molecular features that predict for poor response to fludarabine and rituximab induction and subsequent alemtuzumab consolidation therapy.
-
To assess preliminarily the molecular features of CLL at relapse in patients responding to chemoimmunotherapy for CLL.
-
To determine the frequency of patients who remain at high risk for progression of CLL despite this therapy and who are thus eligible for nonmyeloablative stem cell transplantation studies such as CALGB 109901.
-
To perform limited rituximab pharmacokinetics to determine the ideal schedule of administration for a subsequent rituximab maintenance treatment approach following induction therapy with fludarabine and rituximab.
OUTLINE:
Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression.
Patients are followed at 2 months, every 3 months for 1 year, and then every 6 months for 7 years from study entry.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (alemtuzumab, rituximab, fludarabine phosphate) Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression. |
Biological: alemtuzumab
Given SC
Other Names:
Biological: rituximab
Given IV
Other Names:
Drug: fludarabine phosphate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab [Duration of treatment (up to 13.5 months)]
A complete response, as defined by the National Cancer Institute Working Group (NCIWG): - CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy
Secondary Outcome Measures
- Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab [Up to 9 months]
Response, as defined by the National Cancer Institute Working Group (NCIWG): 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/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
- 2 Year Progression Free Survival [2 years from registration]
Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method.
- 2 Year Survival [2 years from registration]
Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
- Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab [6 weeks beginning at study week 36]
The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Specific Diagnosis of B-Cell CLL
-
An absolute lymphocytosis of > 5,000/μL
-
Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
-
Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; the overall cellularity must be normocellular or hypercellular
-
Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression
-
Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV)
-
Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
-
Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
-
Presence of weight loss > 10% over the preceding 6 month period;
-
Grade 2 or 3 fatigue;
-
Fevers > 100.5°F or night sweats for greater than 2 weeks without evidence of infection;
-
Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
-
No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL
-
No medical condition requiring chronic use of oral corticosteroids
-
Performance Status 0 - 2
-
Due to alterations in host immunity, patients with HIV may not be enrolled
-
Due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
-
Creatinine =< 1.5 x upper limit of institutional normal value
-
Coomb's Testing NEGATIVE
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer and Leukemia Group B | Chicago | Illinois | United States | 60606 |
| 2 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Thomas Lin, Cancer and Leukemia Group B
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-02812
- NCI-2012-02812
- CDR0000398139
- CALGB-10101
- CALGB-10101
- P30CA014236
- U10CA031946
Study Results
Participant Flow
| Recruitment Details | Between January 2005 and December 2006, 103 participants were recruited. |
|---|---|
| Pre-assignment Detail | One participant was deemed ineligible and is excluded from all analyses per study design. |
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Period Title: Overall Study | |
| STARTED | 102 |
| COMPLETED | 102 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Overall Participants | 102 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
61
|
| Sex: Female, Male (Count of Participants) | |
| Female |
27
26.5%
|
| Male |
75
73.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
102
100%
|
| Rai Stage (participants) [Number] | |
| Stage 0 |
1
1%
|
| Stage I-II |
71
69.6%
|
| Stage III-IV |
30
29.4%
|
Outcome Measures
| Title | Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab |
|---|---|
| Description | A complete response, as defined by the National Cancer Institute Working Group (NCIWG): - CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy |
| Time Frame | Duration of treatment (up to 13.5 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 58 participants were treated with Alemtuzumab. |
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Measure Participants | 58 |
| Number [participants] |
38
37.3%
|
| Title | Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab |
|---|---|
| Description | Response, as defined by the National Cancer Institute Working Group (NCIWG): 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/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions |
| Time Frame | Up to 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Measure Participants | 102 |
| Number [participants] |
92
90.2%
|
| Title | 2 Year Progression Free Survival |
|---|---|
| Description | Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method. |
| Time Frame | 2 years from registration |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Measure Participants | 102 |
| Number [percentage of participants] |
72
70.6%
|
| Title | 2 Year Survival |
|---|---|
| Description | Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method. |
| Time Frame | 2 years from registration |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Measure Participants | 102 |
| Number [percentage of participants] |
86
84.3%
|
| Title | Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab |
|---|---|
| Description | The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. |
| Time Frame | 6 weeks beginning at study week 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 58 participants were treatment with Alemtuzumab. |
| Arm/Group Title | Alemtuzumab Consolidation |
|---|---|
| Arm/Group Description | Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL |
| Measure Participants | 58 |
| Number [participants] |
23
22.5%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | FR Induction | Alemtuzumab Consolidation | ||
| Arm/Group Description | Fludarabine and rituximab induction in pts with B-cell CLL | Alemtuzumab consolidation following fludarabine and rituximab induction | ||
All Cause Mortality |
||||
| FR Induction | Alemtuzumab Consolidation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| FR Induction | Alemtuzumab Consolidation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/102 (18.6%) | 23/58 (39.7%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 5/102 (4.9%) | 6 | 7/58 (12.1%) | 7 |
| Hemoglobin decreased | 12/102 (11.8%) | 13 | 20/58 (34.5%) | 26 |
| Hemolysis | 0/102 (0%) | 0 | 2/58 (3.4%) | 3 |
| Lymphatic disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Cardiac disorders | ||||
| Atrial fibrillation | 1/102 (1%) | 1 | 2/58 (3.4%) | 3 |
| Atrial flutter | 0/102 (0%) | 0 | 1/58 (1.7%) | 2 |
| Left ventricular failure | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Myocardial ischemia | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Pericardial effusion | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Sinus tachycardia | 0/102 (0%) | 0 | 4/58 (6.9%) | 5 |
| Ventricular tachycardia | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Ear and labyrinth disorders | ||||
| External ear pain | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Eye disorders | ||||
| Vision blurred | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal distension | 0/102 (0%) | 0 | 3/58 (5.2%) | 3 |
| Abdominal pain | 0/102 (0%) | 0 | 3/58 (5.2%) | 3 |
| Ascites | 0/102 (0%) | 0 | 2/58 (3.4%) | 3 |
| Colitis | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Constipation | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Diarrhea | 4/102 (3.9%) | 4 | 5/58 (8.6%) | 5 |
| Dysphagia | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Gastritis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Ileus | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Nausea | 7/102 (6.9%) | 7 | 7/58 (12.1%) | 8 |
| Upper gastrointestinal hemorrhage | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Vomiting | 3/102 (2.9%) | 3 | 4/58 (6.9%) | 4 |
| General disorders | ||||
| Chest pain | 2/102 (2%) | 2 | 2/58 (3.4%) | 2 |
| Chills | 4/102 (3.9%) | 4 | 4/58 (6.9%) | 4 |
| Edema limbs | 4/102 (3.9%) | 4 | 3/58 (5.2%) | 3 |
| Fatigue | 12/102 (11.8%) | 12 | 19/58 (32.8%) | 23 |
| Fever | 5/102 (4.9%) | 5 | 9/58 (15.5%) | 10 |
| Flu-like symptoms | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Hypothermia | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Localized edema | 3/102 (2.9%) | 3 | 1/58 (1.7%) | 1 |
| Multi-organ failure | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Visceral edema | 0/102 (0%) | 0 | 1/58 (1.7%) | 2 |
| Hepatobiliary disorders | ||||
| Hepatic failure | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Hepatobiliary disease | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Immune system disorders | ||||
| Hypersensitivity | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Infections and infestations | ||||
| Bladder infection | 0/102 (0%) | 0 | 3/58 (5.2%) | 3 |
| Encephalomyelitis infection | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Infectious meningitis | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Mucosal infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Opportunistic infection | 0/102 (0%) | 0 | 3/58 (5.2%) | 4 |
| Pneumonia | 2/102 (2%) | 2 | 5/58 (8.6%) | 7 |
| Sepsis | 1/102 (1%) | 1 | 8/58 (13.8%) | 8 |
| Sinusitis | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Skin infection | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Upper aerodigestive tract infection | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Upper respiratory infection | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Urinary tract infection | 1/102 (1%) | 1 | 3/58 (5.2%) | 3 |
| Vaginal infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Bruising | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Tracheal hemorrhage | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Investigations | ||||
| Activated partial thromboplastin time prolonged | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Alanine aminotransferase increased | 2/102 (2%) | 2 | 9/58 (15.5%) | 11 |
| Alkaline phosphatase increased | 0/102 (0%) | 0 | 6/58 (10.3%) | 7 |
| Amylase increased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Aspartate aminotransferase increased | 2/102 (2%) | 3 | 9/58 (15.5%) | 11 |
| Blood bilirubin increased | 2/102 (2%) | 2 | 5/58 (8.6%) | 6 |
| CD4 lymphocytes decreased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Creatine phosphokinase increased | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Creatinine increased | 3/102 (2.9%) | 4 | 5/58 (8.6%) | 8 |
| Haptoglobin decreased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| INR increased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Laboratory test abnormal | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Leukocyte count decreased | 3/102 (2.9%) | 3 | 7/58 (12.1%) | 9 |
| Lipase increased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Lymphocyte count decreased | 1/102 (1%) | 1 | 5/58 (8.6%) | 8 |
| Neutrophil count decreased | 13/102 (12.7%) | 14 | 14/58 (24.1%) | 20 |
| Platelet count decreased | 13/102 (12.7%) | 14 | 18/58 (31%) | 25 |
| Weight gain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Weight loss | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 4/102 (3.9%) | 4 | 5/58 (8.6%) | 6 |
| Blood bicarbonate decreased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Blood glucose increased | 5/102 (4.9%) | 6 | 11/58 (19%) | 14 |
| Blood uric acid increased | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Dehydration | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Iron overload | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Serum albumin decreased | 2/102 (2%) | 2 | 5/58 (8.6%) | 5 |
| Serum calcium decreased | 3/102 (2.9%) | 3 | 10/58 (17.2%) | 12 |
| Serum glucose decreased | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Serum magnesium decreased | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Serum magnesium increased | 0/102 (0%) | 0 | 3/58 (5.2%) | 3 |
| Serum phosphate decreased | 3/102 (2.9%) | 3 | 2/58 (3.4%) | 2 |
| Serum potassium decreased | 3/102 (2.9%) | 3 | 4/58 (6.9%) | 4 |
| Serum potassium increased | 0/102 (0%) | 0 | 3/58 (5.2%) | 3 |
| Serum sodium decreased | 2/102 (2%) | 2 | 10/58 (17.2%) | 11 |
| Serum sodium increased | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Arthritis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Back pain | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Chest wall pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Muscle weakness | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Myalgia | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Myositis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Neck pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Pain in extremity | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Treatment related secondary malignancy | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Nervous system disorders | ||||
| Depressed level of consciousness | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Dizziness | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Headache | 4/102 (3.9%) | 4 | 7/58 (12.1%) | 8 |
| Intracranial hemorrhage | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Ischemia cerebrovascular | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Memory impairment | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Mini mental status examination abnormal | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Neuralgia | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Peripheral motor neuropathy | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Peripheral sensory neuropathy | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Seizure | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Trigeminal nerve disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Psychiatric disorders | ||||
| Agitation | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Anxiety | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Confusion | 2/102 (2%) | 2 | 3/58 (5.2%) | 3 |
| Depression | 1/102 (1%) | 1 | 4/58 (6.9%) | 4 |
| Insomnia | 3/102 (2.9%) | 3 | 1/58 (1.7%) | 1 |
| Renal and urinary disorders | ||||
| Bladder spasm | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Glomerular filtration rate decreased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Hemorrhage urinary tract | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Proteinuria | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Renal failure | 0/102 (0%) | 0 | 2/58 (3.4%) | 3 |
| Renal hemorrhage | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Urinary frequency | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Urinary incontinence | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Urinary retention | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Urine discoloration | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Urogenital disorder | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Reproductive system and breast disorders | ||||
| Prostatic obstruction | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Testicular pain | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Adult respiratory distress syndrome | 0/102 (0%) | 0 | 2/58 (3.4%) | 3 |
| Allergic rhinitis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Bronchospasm | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Cough | 5/102 (4.9%) | 5 | 4/58 (6.9%) | 4 |
| Dyspnea | 8/102 (7.8%) | 9 | 10/58 (17.2%) | 12 |
| Epistaxis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Hypoxia | 0/102 (0%) | 0 | 2/58 (3.4%) | 3 |
| Pharyngolaryngeal pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Pleural effusion | 0/102 (0%) | 0 | 3/58 (5.2%) | 4 |
| Pneumonitis | 1/102 (1%) | 1 | 2/58 (3.4%) | 3 |
| Respiratory disorder | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Voice alteration | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Petechiae | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Pruritus | 1/102 (1%) | 2 | 2/58 (3.4%) | 2 |
| Rash desquamating | 6/102 (5.9%) | 6 | 8/58 (13.8%) | 9 |
| Skin hypopigmentation | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Sweating | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Urticaria | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Vascular disorders | ||||
| Hematoma | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Hemorrhage | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Hot flashes | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Hypertension | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Hypotension | 3/102 (2.9%) | 3 | 6/58 (10.3%) | 9 |
| Thrombosis | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| FR Induction | Alemtuzumab Consolidation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 101/102 (99%) | 55/58 (94.8%) | ||
| Blood and lymphatic system disorders | ||||
| Blood disorder | 1/102 (1%) | 9 | 0/58 (0%) | 0 |
| Febrile neutropenia | 12/102 (11.8%) | 13 | 5/58 (8.6%) | 6 |
| Hemoglobin decreased | 73/102 (71.6%) | 183 | 38/58 (65.5%) | 89 |
| Hemolysis | 2/102 (2%) | 5 | 2/58 (3.4%) | 2 |
| Lymph node pain | 2/102 (2%) | 3 | 2/58 (3.4%) | 2 |
| Lymphatic disorder | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Cardiac disorders | ||||
| Atrial fibrillation | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Cardiac disorder | 1/102 (1%) | 2 | 3/58 (5.2%) | 6 |
| Myocardial ischemia | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Palpitations | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Pericarditis | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Sinus tachycardia | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Ear pain | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| External ear inflammation | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Hearing impaired | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Tinnitus | 2/102 (2%) | 2 | 1/58 (1.7%) | 4 |
| Endocrine disorders | ||||
| Hypothyroidism | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Eye disorders | ||||
| Cataract | 2/102 (2%) | 5 | 1/58 (1.7%) | 1 |
| Dry eye syndrome | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Eye disorder | 4/102 (3.9%) | 4 | 1/58 (1.7%) | 1 |
| Eye pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Eyelid function disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Glaucoma | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Optic nerve edema | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Photophobia | 1/102 (1%) | 1 | 1/58 (1.7%) | 2 |
| Vision blurred | 3/102 (2.9%) | 3 | 1/58 (1.7%) | 1 |
| Watering eyes | 4/102 (3.9%) | 5 | 0/58 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal distension | 3/102 (2.9%) | 6 | 1/58 (1.7%) | 1 |
| Abdominal pain | 11/102 (10.8%) | 18 | 3/58 (5.2%) | 4 |
| Ascites | 1/102 (1%) | 3 | 0/58 (0%) | 0 |
| Colitis | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Colonic hemorrhage | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Constipation | 29/102 (28.4%) | 51 | 3/58 (5.2%) | 3 |
| Diarrhea | 25/102 (24.5%) | 34 | 18/58 (31%) | 29 |
| Dry mouth | 4/102 (3.9%) | 4 | 1/58 (1.7%) | 1 |
| Dyspepsia | 5/102 (4.9%) | 6 | 2/58 (3.4%) | 2 |
| Dysphagia | 2/102 (2%) | 3 | 0/58 (0%) | 0 |
| Ear, nose and throat examination abnormal | 3/102 (2.9%) | 5 | 4/58 (6.9%) | 5 |
| Esophageal pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Flatulence | 3/102 (2.9%) | 3 | 1/58 (1.7%) | 1 |
| Gastrointestinal disorder | 4/102 (3.9%) | 6 | 1/58 (1.7%) | 1 |
| Hemorrhoids | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Lower gastrointestinal hemorrhage | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Mucositis oral | 4/102 (3.9%) | 4 | 1/58 (1.7%) | 2 |
| Nausea | 58/102 (56.9%) | 104 | 20/58 (34.5%) | 24 |
| Oral pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Periodontal disease | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Rectal hemorrhage | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Rectal pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Small intestinal obstruction | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Stomach pain | 0/102 (0%) | 0 | 1/58 (1.7%) | 2 |
| Tooth disorder | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Toothache | 2/102 (2%) | 3 | 0/58 (0%) | 0 |
| Vomiting | 24/102 (23.5%) | 30 | 7/58 (12.1%) | 7 |
| General disorders | ||||
| Chest pain | 8/102 (7.8%) | 11 | 2/58 (3.4%) | 4 |
| Chills | 28/102 (27.5%) | 32 | 13/58 (22.4%) | 15 |
| Edema limbs | 6/102 (5.9%) | 9 | 6/58 (10.3%) | 6 |
| Facial pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Fatigue | 84/102 (82.4%) | 200 | 44/58 (75.9%) | 106 |
| Fever | 26/102 (25.5%) | 33 | 14/58 (24.1%) | 18 |
| Flu-like symptoms | 3/102 (2.9%) | 4 | 0/58 (0%) | 0 |
| Gait abnormal | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| General symptom | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Ill-defined disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Injection site reaction | 1/102 (1%) | 1 | 7/58 (12.1%) | 7 |
| Localized edema | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Pain | 11/102 (10.8%) | 11 | 6/58 (10.3%) | 10 |
| Hepatobiliary disorders | ||||
| Hepatic failure | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Immune system disorders | ||||
| Hypersensitivity | 9/102 (8.8%) | 9 | 4/58 (6.9%) | 5 |
| Immune system disorder | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Infections and infestations | ||||
| Bladder infection | 2/102 (2%) | 3 | 1/58 (1.7%) | 1 |
| Bronchitis | 4/102 (3.9%) | 4 | 5/58 (8.6%) | 5 |
| Catheter related infection | 0/102 (0%) | 0 | 2/58 (3.4%) | 3 |
| Conjunctivitis infective | 2/102 (2%) | 2 | 2/58 (3.4%) | 2 |
| Cranial nerve infection | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Eye infection | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Gallbladder infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Gastric infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Gingival infection | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Hepatic infection | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Infection | 4/102 (3.9%) | 7 | 8/58 (13.8%) | 11 |
| Infectious colitis | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Lip infection | 3/102 (2.9%) | 5 | 0/58 (0%) | 0 |
| Lymph gland infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Opportunistic infection | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Otitis externa | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Otitis media | 1/102 (1%) | 2 | 1/58 (1.7%) | 1 |
| Pancreas infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Paranasal sinus infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Penile infection | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Peripheral nerve infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Pharyngitis | 4/102 (3.9%) | 5 | 0/58 (0%) | 0 |
| Pneumonia | 7/102 (6.9%) | 11 | 5/58 (8.6%) | 6 |
| Rhinitis infective | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Scrotal infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Sepsis | 1/102 (1%) | 1 | 10/58 (17.2%) | 11 |
| Sinusitis | 10/102 (9.8%) | 15 | 5/58 (8.6%) | 8 |
| Skin infection | 4/102 (3.9%) | 5 | 2/58 (3.4%) | 2 |
| Soft tissue infection | 1/102 (1%) | 1 | 3/58 (5.2%) | 3 |
| Stoma site infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Tooth infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Upper respiratory infection | 14/102 (13.7%) | 18 | 11/58 (19%) | 15 |
| Ureteritis | 3/102 (2.9%) | 4 | 1/58 (1.7%) | 1 |
| Urinary tract infection | 6/102 (5.9%) | 7 | 2/58 (3.4%) | 3 |
| Vaginal infection | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Biliary anastomotic leak | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Bruising | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Postoperative hemorrhage | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Small intestinal anastomotic leak | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Thermal burn | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Venous injury - Extremity-upper | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 18/102 (17.6%) | 41 | 9/58 (15.5%) | 19 |
| Alkaline phosphatase increased | 9/102 (8.8%) | 11 | 8/58 (13.8%) | 13 |
| Aspartate aminotransferase increased | 28/102 (27.5%) | 60 | 10/58 (17.2%) | 19 |
| Blood bilirubin increased | 16/102 (15.7%) | 37 | 7/58 (12.1%) | 16 |
| CD4 lymphocytes decreased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Creatine phosphokinase increased | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Creatinine increased | 20/102 (19.6%) | 41 | 10/58 (17.2%) | 23 |
| Gamma-glutamyltransferase increased | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Haptoglobin decreased | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Laboratory test abnormal | 9/102 (8.8%) | 11 | 4/58 (6.9%) | 6 |
| Leukocyte count decreased | 41/102 (40.2%) | 97 | 22/58 (37.9%) | 37 |
| Lymphocyte count decreased | 26/102 (25.5%) | 68 | 15/58 (25.9%) | 32 |
| Neutrophil count decreased | 78/102 (76.5%) | 215 | 39/58 (67.2%) | 96 |
| Platelet count decreased | 69/102 (67.6%) | 194 | 33/58 (56.9%) | 113 |
| Serum cholesterol increased | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Weight gain | 2/102 (2%) | 5 | 0/58 (0%) | 0 |
| Weight loss | 3/102 (2.9%) | 3 | 3/58 (5.2%) | 3 |
| Metabolism and nutrition disorders | ||||
| Alkalosis | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Anorexia | 14/102 (13.7%) | 15 | 8/58 (13.8%) | 8 |
| Blood bicarbonate decreased | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Blood glucose increased | 43/102 (42.2%) | 118 | 18/58 (31%) | 51 |
| Blood uric acid increased | 6/102 (5.9%) | 8 | 2/58 (3.4%) | 2 |
| Dehydration | 5/102 (4.9%) | 6 | 1/58 (1.7%) | 2 |
| Glucose intolerance | 2/102 (2%) | 7 | 1/58 (1.7%) | 1 |
| Serum albumin decreased | 6/102 (5.9%) | 8 | 4/58 (6.9%) | 4 |
| Serum calcium decreased | 21/102 (20.6%) | 34 | 13/58 (22.4%) | 17 |
| Serum calcium increased | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Serum glucose decreased | 8/102 (7.8%) | 8 | 3/58 (5.2%) | 7 |
| Serum magnesium decreased | 1/102 (1%) | 2 | 0/58 (0%) | 0 |
| Serum magnesium increased | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Serum phosphate decreased | 8/102 (7.8%) | 9 | 4/58 (6.9%) | 4 |
| Serum potassium decreased | 9/102 (8.8%) | 20 | 6/58 (10.3%) | 6 |
| Serum potassium increased | 7/102 (6.9%) | 9 | 4/58 (6.9%) | 4 |
| Serum sodium decreased | 12/102 (11.8%) | 18 | 7/58 (12.1%) | 8 |
| Serum sodium increased | 3/102 (2.9%) | 3 | 0/58 (0%) | 0 |
| Serum triglycerides increased | 2/102 (2%) | 3 | 1/58 (1.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 21/102 (20.6%) | 34 | 8/58 (13.8%) | 12 |
| Arthritis | 4/102 (3.9%) | 5 | 0/58 (0%) | 0 |
| Back pain | 18/102 (17.6%) | 25 | 5/58 (8.6%) | 11 |
| Bone pain | 6/102 (5.9%) | 8 | 3/58 (5.2%) | 3 |
| Chest wall pain | 3/102 (2.9%) | 5 | 0/58 (0%) | 0 |
| Joint disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Muscle weakness | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Muscle weakness lower limb | 1/102 (1%) | 1 | 1/58 (1.7%) | 2 |
| Muscle weakness upper limb | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Musculoskeletal disorder | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Myalgia | 19/102 (18.6%) | 24 | 10/58 (17.2%) | 12 |
| Myositis | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Neck pain | 5/102 (4.9%) | 7 | 2/58 (3.4%) | 2 |
| Pain in extremity | 13/102 (12.7%) | 20 | 3/58 (5.2%) | 4 |
| Upper extremity dysfunction | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Treatment related secondary malignancy | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Tumor flare | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Tumor pain | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Nervous system disorders | ||||
| Dizziness | 11/102 (10.8%) | 16 | 4/58 (6.9%) | 5 |
| Dysgeusia | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Extrapyramidal disorder | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Headache | 27/102 (26.5%) | 47 | 15/58 (25.9%) | 19 |
| Memory impairment | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Neuralgia | 1/102 (1%) | 1 | 2/58 (3.4%) | 6 |
| Neurological disorder NOS | 3/102 (2.9%) | 3 | 3/58 (5.2%) | 3 |
| Peripheral motor neuropathy | 5/102 (4.9%) | 5 | 3/58 (5.2%) | 3 |
| Peripheral sensory neuropathy | 11/102 (10.8%) | 16 | 3/58 (5.2%) | 3 |
| Sinus pain | 1/102 (1%) | 2 | 1/58 (1.7%) | 2 |
| Speech disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Syncope | 1/102 (1%) | 2 | 0/58 (0%) | 0 |
| Syncope vasovagal | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Tremor | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Trigeminal nerve disorder | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Psychiatric disorders | ||||
| Anxiety | 7/102 (6.9%) | 10 | 4/58 (6.9%) | 7 |
| Confusion | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Depression | 13/102 (12.7%) | 16 | 7/58 (12.1%) | 10 |
| Insomnia | 17/102 (16.7%) | 26 | 9/58 (15.5%) | 10 |
| Psychosis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Renal and urinary disorders | ||||
| Bladder hemorrhage | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Bladder pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Dysuria (painful urination) | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Glomerular filtration rate decreased | 5/102 (4.9%) | 7 | 0/58 (0%) | 0 |
| Hemorrhage urinary tract | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Proteinuria | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Renal failure | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Urinary frequency | 6/102 (5.9%) | 8 | 4/58 (6.9%) | 4 |
| Urinary retention | 3/102 (2.9%) | 4 | 0/58 (0%) | 0 |
| Urine discoloration | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Urogenital disorder | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Reproductive system and breast disorders | ||||
| Erectile dysfunction | 1/102 (1%) | 3 | 1/58 (1.7%) | 2 |
| Pelvic pain | 1/102 (1%) | 2 | 0/58 (0%) | 0 |
| Testicular pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Vaginal dryness | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Allergic rhinitis | 14/102 (13.7%) | 17 | 7/58 (12.1%) | 9 |
| Bronchospasm | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Cough | 25/102 (24.5%) | 44 | 29/58 (50%) | 43 |
| Dyspnea | 19/102 (18.6%) | 31 | 16/58 (27.6%) | 27 |
| Epistaxis | 3/102 (2.9%) | 4 | 6/58 (10.3%) | 9 |
| Hypoxia | 3/102 (2.9%) | 3 | 1/58 (1.7%) | 2 |
| Nasal congestion | 2/102 (2%) | 3 | 2/58 (3.4%) | 2 |
| Pharyngeal examination abnormal | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Pharyngolaryngeal pain | 5/102 (4.9%) | 9 | 4/58 (6.9%) | 4 |
| Pleural effusion | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Pleuritic pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Pneumonitis | 2/102 (2%) | 2 | 2/58 (3.4%) | 2 |
| Pneumothorax | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Respiratory disorder | 2/102 (2%) | 2 | 1/58 (1.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 5/102 (4.9%) | 6 | 0/58 (0%) | 0 |
| Decubitus ulcer | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Dry skin | 5/102 (4.9%) | 8 | 3/58 (5.2%) | 4 |
| Hand-and-foot syndrome | 1/102 (1%) | 2 | 1/58 (1.7%) | 2 |
| Nail disorder | 1/102 (1%) | 2 | 0/58 (0%) | 0 |
| Pain of skin | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Petechiae | 0/102 (0%) | 0 | 2/58 (3.4%) | 2 |
| Photosensitivity | 1/102 (1%) | 1 | 2/58 (3.4%) | 2 |
| Pruritus | 15/102 (14.7%) | 19 | 14/58 (24.1%) | 20 |
| Rash acneiform | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Rash desquamating | 48/102 (47.1%) | 69 | 33/58 (56.9%) | 57 |
| Scalp pain | 1/102 (1%) | 1 | 0/58 (0%) | 0 |
| Skin disorder | 4/102 (3.9%) | 4 | 2/58 (3.4%) | 5 |
| Skin induration | 1/102 (1%) | 2 | 0/58 (0%) | 0 |
| Sweating | 21/102 (20.6%) | 29 | 13/58 (22.4%) | 22 |
| Urticaria | 3/102 (2.9%) | 3 | 5/58 (8.6%) | 5 |
| Vascular disorders | ||||
| Flushing | 2/102 (2%) | 2 | 0/58 (0%) | 0 |
| Hematoma | 1/102 (1%) | 1 | 1/58 (1.7%) | 1 |
| Hemorrhage | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
| Hot flashes | 4/102 (3.9%) | 7 | 3/58 (5.2%) | 6 |
| Hypertension | 6/102 (5.9%) | 11 | 4/58 (6.9%) | 8 |
| Hypotension | 17/102 (16.7%) | 24 | 6/58 (10.3%) | 6 |
| Phlebitis | 1/102 (1%) | 2 | 0/58 (0%) | 0 |
| Thrombosis | 0/102 (0%) | 0 | 1/58 (1.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Thomas Lin |
|---|---|
| Organization | The Ohio State University |
| Phone | |
| thomas.lin@osumc.edu |
- NCI-2012-02812
- NCI-2012-02812
- CDR0000398139
- CALGB-10101
- CALGB-10101
- P30CA014236
- U10CA031946