Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OUTLINE: This is a multicenter study. The purpose of this study is to improve the outcome of adolescents and young adults with acute lymphoblastic leukemia (ALL). The objectives of the study are described below.
OBJECTIVES:
-
To describe the outcomes (i.e., complete response rate, event-free survival, disease-free survival [DFS], and overall survival [OS]) of adolescents and young adults with newly diagnosed acute lymphoblastic leukemia (ALL) treated with a pediatric chemotherapy regimen by adult hematologists/oncologists at multiple sites.
-
To explore the feasibility of extending the "pediatric approach" to adult patients up to 40 years of age.
-
To estimate the DFS and OS of these patients.
-
To describe the toxicities observed in these patients.
-
To compare the outcomes of patients treated on this protocol with appropriate similar patients (by age and disease characteristics) treated by pediatric oncologists on protocol COG-AALL0232.
-
To evaluate the adherence of adult hematologists/oncologists and their patients to a "pediatric" ALL treatment regimen and identify reasons for variances.
-
To analyze and describe the outcomes of patients treated on this study according to pretreatment characteristics such as age, gender, white blood cell count, other hematologic parameters, blood chemistry, immunophenotype, cytogenetics and molecular genetic characteristics, and treatment variables such as treatment site (academic center or community), and protocol adherence.
-
To analyze and describe the outcomes of patients treated on this study according to baseline psychosocial characteristics, demographics, and family support.
The courses of treatment for the research study are described below.
- Remission induction therapy: Patients receive intrathecal (IT) cytarabine on day 1; vincristine IV on days 1, 8, 15, and 22; prednisone IV or orally twice daily on days 1-28; daunorubicin hydrochloride IV on days 1, 8, 15, and 22; pegaspargase IV or intramuscularly (IM) on day 4 or 5 or 6; and IT methotrexate on days 8 and 29*. Patients undergo bone marrow aspirate (BMA) and biopsy on day 29 to assess induction response and minimal residual disease status. Patients with M1 marrow (< 1% lymphoblasts) proceed to remission consolidation therapy. Patients with M2 marrow (> 5% but < 25% lymphoblasts) proceed to extended remission induction therapy. Patients with M3 marrow are removed from protocol therapy.
NOTE: *Patients with CNS3 disease also receive IT methotrexate on days 15 and 22.
- Extended remission induction therapy: Patients receive prednisone IV or orally twice daily on days 1-14; vincristine IV on days 1 and 8; pegaspargase IM or IV on day 4 or 5 or 6; and daunorubicin hydrochloride IV on day 1. Patients undergo BMA and biopsy on day
- Patients with M1 marrow proceed to remission consolidation therapy. Patients with M2 or M3 bone marrow are removed from protocol therapy.
- Remission consolidation therapy: Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM or IV on days 15 and 43; and IT methotrexate on days 1, 8, 15*, and 22*. Once blood counts recover, patients proceed to interim maintenance therapy.
NOTE: *Patients with CNS3 disease do not receive IT methotrexate on days 15 and 22.
-
Interim maintenance therapy: Patients receive vincristine IV and methotrexate (Capizzi methotrexate) IV on days 1, 11, 21, 31, and 41; pegaspargase IM or IV on days 2 and 22; and IT methotrexate on days 1 and 31. Once blood counts recover (ANC ≥ 750/mm3 and platelet count ≥ 75,000/mm3), patients proceed to delayed intensification therapy.
-
Delayed intensification therapy: Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone IV or orally twice daily on days 1-7 and 15-21; doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV on day 4 or 5 or 6 AND day 43; cyclophosphamide IV on day 29; cytarabine IV or SC on days 29-32 and 36-39; oral thioguanine on days 29-42; and IT methotrexate on days 1, 29, and 36. Once blood counts recover, patients proceed to maintenance therapy.
-
Maintenance therapy: Patients receive vincristine IV on days 1, 29, and 57; dexamethasone IV or orally twice daily on days 1-5, 29-33, and 57-61; mercaptopurine orally on days 1-84; IT methotrexate on day 1*; and oral methotrexate on days 8, 15, 22, 29**, 36, 43, 50, 57, 64, 71, and 78.
Treatment repeats every 12 weeks for 2 years from the start of interim maintenance (for female patients) or 3 years from the start of interim maintenance (for male patients).
NOTE: *IT methotrexate is also given on day 29 of the first 4 courses of maintenance therapy.
NOTE: **Oral methotrexate is held on day 29 of the first 4 courses of maintenance therapy (when IT methotrexate is given).
- Radiotherapy: During the first course of maintenance therapy, patients with testicular disease undergo concurrent radiotherapy to the testes 5 days a week for 2.5 weeks (total dose 2400 cGy given in 12 daily fractions); patients with CNS3 disease undergo concurrent cranial radiotherapy 5 days a week for 2 weeks (total dose of 1800 cGy given in 10 daily fractions); and patients with T-cell ALL undergo concurrent cranial radiotherapy (total dose of 2400 cGy given in 10 daily fractions) 5 days a week for 2 weeks.
Patients may complete surveys at the end of courses 1, 2, and 4, at the end of all protocol treatment, and at 6 and 18 months after the end of all protocol treatment.
After completion of study treatment, patients are followed every 1-3 months for 3 years and then every 6 months for 7 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (chemotherapy, radiotherapy) Patients are given a series of leukemia treatments that are divided into several sequential courses and different chemotherapy combinations of treatment. Please see the "Detailed Description" section for more information. |
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy
|
Outcome Measures
Primary Outcome Measures
- Complete Response Rate [Up to 8 years post-registration]
Complete response rate is defined as the percentage of patients who achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) at the end of induction therapy.
- Event-free Survival [Up to 8 years post-registration]
EFS was defined as time from registration in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.
- Disease-free Survival [Up to 8 years post-registration]
DFS was defined as time from bone marrow response in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.
- Overall Survival [Up to 8 years post-registration]
OS was defined from registration to death resulting from any cause.
- Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity) [Up to 10 years post-registration]
The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below.
Other Outcome Measures
- Analysis and Description of the Outcomes of Patients Treated on This Study According to Baseline Psychosocial Characteristics, Demographics, and Family Support [Up to 10 years post-registration]
- Outcomes of Patients Treated on This Study According to Pretreatment Characteristics Such as Age, Gender, White Blood Cell Count, Other Hematologic Parameters, Blood Chemistry, Immunophenotype, Cytogenetics and Molecular Genetic Characteristics [Up to 10 years post-registration]
- Adherence of Adult Hematologists/Oncologists and Their Patients to a "Pediatric" Acute Lymphoblastic Leukemia Treatment Regimen and Identification of Reasons for Variances [Up to 10 years post-registration]
- Outcomes of Adolescent and Young Adult Patients Treated on This Study Compared With Those of Patients Treated Per COG-AALL0232 [Up to 10 years post-registration]
Eligibility Criteria
Criteria
Eligibility Criteria:
-
Diagnosis
-
Newly diagnosed patients with either B-precursor or T-precursor acute lymphoblastic leukemia (WHO criteria). Burkitt type leukemia as defined per protocol is not eligible. Patients known to have Ph+ ALL at time of diagnosis are not eligible.
-
CALGB patients entered on CALGB 10403 who are later found to meet the following criteria for Ph+ ALL should have treatment on this trial discontinued and should be encouraged to enroll on CALGB 10001 or its successor trial:
-
BCR-ABL fusion transcript determined by FISH or RT-PCR
-
t(9;22)(q34;q11) or variant determined by cytogenetics
Non-CALGB study participants who are later found to be Ph+ should have treatment on this trial discontinued and should be encouraged to enroll on an appropriate clinical trial specifically designed for Ph+ ALL.
-
Age: 16 - 39 years
-
ECOG Performance Status 0-2
-
Patients with Down Syndrome are excluded from this study due to the likelihood of excessive toxicity resulting. These patients should be treated in consultation with a pediatric oncologist.
-
Prior Therapy - No prior therapy except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.
-
No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC.
-
Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systemic therapy for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
-
Patients receiving prior steroid therapy are eligible for study. The dose and duration of previous steroid therapy should be carefully documented on case report forms.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Wendy Stock, M.D., University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
- CALGB-10403
- CALGB-10403
- ECOG C10403
- CDR0000574230
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Period Title: Overall Study | |
STARTED | 318 |
COMPLETED | 295 |
NOT COMPLETED | 23 |
Baseline Characteristics
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Overall Participants | 295 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
24.0
|
Sex: Female, Male (Count of Participants) | |
Female |
115
39%
|
Male |
180
61%
|
Outcome Measures
Title | Complete Response Rate |
---|---|
Description | Complete response rate is defined as the percentage of patients who achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) at the end of induction therapy. |
Time Frame | Up to 8 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Measure Participants | 295 |
Number (95% Confidence Interval) [percentage of patients] |
89
|
Title | Event-free Survival |
---|---|
Description | EFS was defined as time from registration in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease. |
Time Frame | Up to 8 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Measure Participants | 295 |
Median (95% Confidence Interval) [months] |
78.1
|
Title | Disease-free Survival |
---|---|
Description | DFS was defined as time from bone marrow response in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease. |
Time Frame | Up to 8 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Measure Participants | 295 |
Median (95% Confidence Interval) [months] |
81.7
|
Title | Overall Survival |
---|---|
Description | OS was defined from registration to death resulting from any cause. |
Time Frame | Up to 8 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Measure Participants | 295 |
Median (95% Confidence Interval) [months] |
NA
|
Title | Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity) |
---|---|
Description | The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below. |
Time Frame | Up to 10 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pediatric Regimen) |
---|---|
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. |
Measure Participants | 295 |
Count of Participants [Participants] |
286
96.9%
|
Title | Analysis and Description of the Outcomes of Patients Treated on This Study According to Baseline Psychosocial Characteristics, Demographics, and Family Support |
---|---|
Description | |
Time Frame | Up to 10 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Outcomes of Patients Treated on This Study According to Pretreatment Characteristics Such as Age, Gender, White Blood Cell Count, Other Hematologic Parameters, Blood Chemistry, Immunophenotype, Cytogenetics and Molecular Genetic Characteristics |
---|---|
Description | |
Time Frame | Up to 10 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Adherence of Adult Hematologists/Oncologists and Their Patients to a "Pediatric" Acute Lymphoblastic Leukemia Treatment Regimen and Identification of Reasons for Variances |
---|---|
Description | |
Time Frame | Up to 10 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Outcomes of Adolescent and Young Adult Patients Treated on This Study Compared With Those of Patients Treated Per COG-AALL0232 |
---|---|
Description | |
Time Frame | Up to 10 years post-registration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Treatment (Pediatric Regimen) | |
Arm/Group Description | Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information. | |
All Cause Mortality |
||
Treatment (Pediatric Regimen) | ||
Affected / at Risk (%) | # Events | |
Total | 105/295 (35.6%) | |
Serious Adverse Events |
||
Treatment (Pediatric Regimen) | ||
Affected / at Risk (%) | # Events | |
Total | 134/295 (45.4%) | |
Blood and lymphatic system disorders | ||
Blood disorder | 4/295 (1.4%) | 4 |
Disseminated intravascular coagulation | 1/295 (0.3%) | 1 |
Febrile neutropenia | 67/295 (22.7%) | 84 |
Hemoglobin decreased | 128/295 (43.4%) | 209 |
Lymph node pain | 1/295 (0.3%) | 1 |
Lymphatic disorder | 3/295 (1%) | 3 |
Cardiac disorders | ||
Arrhythmia | 1/295 (0.3%) | 1 |
Atrial fibrillation | 3/295 (1%) | 4 |
Atrial flutter | 3/295 (1%) | 3 |
Atrial tachycardia | 2/295 (0.7%) | 2 |
Cardiac disorder | 1/295 (0.3%) | 1 |
Cardiac pain | 1/295 (0.3%) | 1 |
Conduction disorder | 1/295 (0.3%) | 1 |
Left ventricular dysfunction | 1/295 (0.3%) | 1 |
Left ventricular failure | 1/295 (0.3%) | 1 |
Myocardial ischemia | 1/295 (0.3%) | 1 |
Palpitations | 4/295 (1.4%) | 5 |
Pericardial effusion | 1/295 (0.3%) | 1 |
Right ventricular dysfunction | 1/295 (0.3%) | 1 |
Sinus arrhythmia | 2/295 (0.7%) | 2 |
Sinus bradycardia | 4/295 (1.4%) | 4 |
Sinus tachycardia | 30/295 (10.2%) | 44 |
Supraventricular tachycardia | 4/295 (1.4%) | 6 |
Ventricular fibrillation | 1/295 (0.3%) | 1 |
Ventricular tachycardia | 4/295 (1.4%) | 4 |
Ear and labyrinth disorders | ||
Ear disorder | 1/295 (0.3%) | 1 |
Ear pain | 6/295 (2%) | 6 |
Hearing impaired | 1/295 (0.3%) | 1 |
Tinnitus | 2/295 (0.7%) | 2 |
Endocrine disorders | ||
Adrenal insufficiency | 1/295 (0.3%) | 1 |
Cushingoid | 5/295 (1.7%) | 6 |
Eye disorders | ||
Dry eye syndrome | 2/295 (0.7%) | 2 |
Extraocular muscle paresis | 2/295 (0.7%) | 2 |
Eye disorder | 4/295 (1.4%) | 4 |
Eye pain | 4/295 (1.4%) | 5 |
Flashing vision | 2/295 (0.7%) | 2 |
Optic nerve edema | 1/295 (0.3%) | 1 |
Photophobia | 2/295 (0.7%) | 2 |
Retinopathy | 1/295 (0.3%) | 1 |
Vision blurred | 13/295 (4.4%) | 14 |
Watering eyes | 1/295 (0.3%) | 1 |
Gastrointestinal disorders | ||
Abdominal distension | 7/295 (2.4%) | 8 |
Abdominal pain | 44/295 (14.9%) | 57 |
Anal hemorrhage | 1/295 (0.3%) | 1 |
Anal pain | 1/295 (0.3%) | 1 |
Colitis | 6/295 (2%) | 8 |
Colonic hemorrhage | 4/295 (1.4%) | 4 |
Colonic perforation | 1/295 (0.3%) | 1 |
Constipation | 39/295 (13.2%) | 46 |
Diarrhea | 49/295 (16.6%) | 63 |
Duodenal ulcer | 1/295 (0.3%) | 1 |
Dyspepsia | 20/295 (6.8%) | 22 |
Dysphagia | 6/295 (2%) | 7 |
Esophageal mucositis (clin exam) | 1/295 (0.3%) | 1 |
Esophageal mucositis (funct/sympt) | 1/295 (0.3%) | 1 |
Esophageal pain | 5/295 (1.7%) | 5 |
Fecal incontinence | 1/295 (0.3%) | 1 |
Gastritis | 4/295 (1.4%) | 4 |
Gastrointestinal disorder | 4/295 (1.4%) | 4 |
Hemorrhoids | 4/295 (1.4%) | 5 |
Ileus | 1/295 (0.3%) | 1 |
Mucositis oral (clin exam) | 30/295 (10.2%) | 33 |
Nausea | 95/295 (32.2%) | 135 |
Oral hemorrhage | 2/295 (0.7%) | 2 |
Oral pain | 12/295 (4.1%) | 12 |
Pancreatic necrosis | 1/295 (0.3%) | 1 |
Pancreatitis | 13/295 (4.4%) | 13 |
Rectal hemorrhage | 3/295 (1%) | 3 |
Rectal pain | 4/295 (1.4%) | 4 |
Stomach pain | 1/295 (0.3%) | 1 |
Tooth disorder | 1/295 (0.3%) | 1 |
Toothache | 4/295 (1.4%) | 4 |
Typhlitis | 4/295 (1.4%) | 4 |
Upper gastrointestinal hemorrhage | 1/295 (0.3%) | 1 |
Vomiting | 64/295 (21.7%) | 84 |
General disorders | ||
Chest pain | 12/295 (4.1%) | 13 |
Chills | 30/295 (10.2%) | 34 |
Disease progression | 1/295 (0.3%) | 1 |
Edema limbs | 26/295 (8.8%) | 31 |
Facial pain | 1/295 (0.3%) | 1 |
Fatigue | 87/295 (29.5%) | 127 |
Fever | 28/295 (9.5%) | 38 |
Flu-like symptoms | 1/295 (0.3%) | 1 |
Gait abnormal | 4/295 (1.4%) | 4 |
General symptom | 6/295 (2%) | 8 |
Ill-defined disorder | 4/295 (1.4%) | 4 |
Injection site reaction | 2/295 (0.7%) | 4 |
Localized edema | 14/295 (4.7%) | 16 |
Multi-organ failure | 1/295 (0.3%) | 1 |
Pain | 29/295 (9.8%) | 41 |
Hepatobiliary disorders | ||
Bile duct stenosis | 1/295 (0.3%) | 2 |
Cholecystitis | 1/295 (0.3%) | 1 |
Hepatic failure | 7/295 (2.4%) | 7 |
Hepatobiliary disease | 5/295 (1.7%) | 5 |
Immune system disorders | ||
Cytokine release syndrome | 1/295 (0.3%) | 1 |
Hypersensitivity | 22/295 (7.5%) | 25 |
Immune system disorder | 2/295 (0.7%) | 2 |
Infections and infestations | ||
Colitis, infectious | 4/295 (1.4%) | 4 |
Opportunistic infection | 1/295 (0.3%) | 1 |
Urinary tract infection(gr 0/1/2 ANC) | 63/295 (21.4%) | 77 |
Injury, poisoning and procedural complications | ||
Aortic injury | 1/295 (0.3%) | 1 |
Bruising | 9/295 (3.1%) | 13 |
Dermatitis radiation | 1/295 (0.3%) | 1 |
Intraop. inj. - Appendix | 1/295 (0.3%) | 1 |
Postoperative hemorrhage | 1/295 (0.3%) | 1 |
Seroma | 1/295 (0.3%) | 1 |
Wound dehiscence | 1/295 (0.3%) | 1 |
Investigations | ||
Activated partial throm time prolonged | 35/295 (11.9%) | 42 |
Alanine aminotransferase increased | 125/295 (42.4%) | 198 |
Alkaline phosphatase increased | 56/295 (19%) | 81 |
Amylase increased | 14/295 (4.7%) | 16 |
Aspartate aminotransferase increased | 116/295 (39.3%) | 187 |
Blood bilirubin increased | 99/295 (33.6%) | 138 |
Blood prolactin abnormal | 1/295 (0.3%) | 1 |
Cardiac troponin I increased | 1/295 (0.3%) | 1 |
Coagulopathy | 4/295 (1.4%) | 5 |
Creatine phosphokinase increased | 1/295 (0.3%) | 1 |
Creatinine increased | 33/295 (11.2%) | 38 |
Electrocardiogram QTc interval prolonged | 2/295 (0.7%) | 2 |
Fibrinogen decreased | 73/295 (24.7%) | 100 |
Gamma-glutamyltransferase increased | 9/295 (3.1%) | 10 |
INR increased | 19/295 (6.4%) | 24 |
Laboratory test abnormal | 16/295 (5.4%) | 19 |
Leukocyte count decreased | 66/295 (22.4%) | 99 |
Lipase increased | 20/295 (6.8%) | 22 |
Lymphocyte count decreased | 45/295 (15.3%) | 65 |
Neutrophil count decreased | 126/295 (42.7%) | 201 |
Platelet count decreased | 126/295 (42.7%) | 197 |
Serum cholesterol increased | 15/295 (5.1%) | 19 |
Weight gain | 7/295 (2.4%) | 8 |
Weight loss | 18/295 (6.1%) | 19 |
Metabolism and nutrition disorders | ||
Acidosis | 3/295 (1%) | 3 |
Anorexia | 36/295 (12.2%) | 46 |
Blood bicarbonate decreased | 8/295 (2.7%) | 11 |
Blood glucose increased | 111/295 (37.6%) | 170 |
Blood uric acid increased | 4/295 (1.4%) | 4 |
Dehydration | 12/295 (4.1%) | 12 |
Glucose intolerance | 7/295 (2.4%) | 7 |
Obesity | 1/295 (0.3%) | 1 |
Renal tubular disorder | 1/295 (0.3%) | 1 |
Serum albumin decreased | 69/295 (23.4%) | 94 |
Serum calcium decreased | 61/295 (20.7%) | 85 |
Serum calcium increased | 7/295 (2.4%) | 7 |
Serum glucose decreased | 30/295 (10.2%) | 38 |
Serum magnesium decreased | 35/295 (11.9%) | 49 |
Serum magnesium increased | 27/295 (9.2%) | 27 |
Serum phosphate decreased | 20/295 (6.8%) | 22 |
Serum potassium decreased | 59/295 (20%) | 81 |
Serum potassium increased | 20/295 (6.8%) | 21 |
Serum sodium decreased | 62/295 (21%) | 90 |
Serum sodium increased | 11/295 (3.7%) | 14 |
Serum triglycerides increased | 24/295 (8.1%) | 33 |
Tumor lysis syndrome | 3/295 (1%) | 3 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 21/295 (7.1%) | 24 |
Back pain | 34/295 (11.5%) | 49 |
Buttock pain | 2/295 (0.7%) | 2 |
Chest wall pain | 10/295 (3.4%) | 12 |
Joint disorder | 3/295 (1%) | 3 |
Muscle weakness | 9/295 (3.1%) | 10 |
Muscle weakness lower limb | 12/295 (4.1%) | 14 |
Muscle weakness right-sided | 2/295 (0.7%) | 2 |
Muscle weakness upper limb | 4/295 (1.4%) | 4 |
Myalgia | 17/295 (5.8%) | 19 |
Myositis | 3/295 (1%) | 3 |
Neck pain | 9/295 (3.1%) | 11 |
Osteonecrosis | 17/295 (5.8%) | 18 |
Osteoporosis | 3/295 (1%) | 3 |
Pain in extremity | 35/295 (11.9%) | 40 |
Soft tissue necrosis lower limb | 1/295 (0.3%) | 1 |
Superficial soft tissue fibrosis | 1/295 (0.3%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Treatment related secondary malignancy | 1/295 (0.3%) | 1 |
Nervous system disorders | ||
Accessory nerve disorder | 1/295 (0.3%) | 1 |
Arachnoiditis | 2/295 (0.7%) | 3 |
Ataxia | 2/295 (0.7%) | 3 |
Central nervous system necrosis | 1/295 (0.3%) | 1 |
Cerebrospinal fluid leakage | 3/295 (1%) | 3 |
Depressed level of consciousness | 5/295 (1.7%) | 7 |
Dizziness | 36/295 (12.2%) | 47 |
Dysgeusia | 9/295 (3.1%) | 9 |
Encephalopathy | 2/295 (0.7%) | 2 |
Extrapyramidal disorder | 1/295 (0.3%) | 1 |
Facial muscle weakness | 1/295 (0.3%) | 1 |
Headache | 86/295 (29.2%) | 118 |
Hypoglossal nerve disorder | 2/295 (0.7%) | 2 |
Intracranial hemorrhage | 2/295 (0.7%) | 2 |
Ischemia cerebrovascular | 2/295 (0.7%) | 2 |
Leukoencephalopathy | 2/295 (0.7%) | 2 |
Memory impairment | 4/295 (1.4%) | 4 |
Mini mental status examination abnormal | 1/295 (0.3%) | 1 |
Neuralgia | 1/295 (0.3%) | 1 |
Neurological disorder NOS | 8/295 (2.7%) | 10 |
Oculomotor nerve disorder | 1/295 (0.3%) | 2 |
Peripheral motor neuropathy | 14/295 (4.7%) | 20 |
Peripheral sensory neuropathy | 68/295 (23.1%) | 97 |
Seizure | 10/295 (3.4%) | 10 |
Speech disorder | 7/295 (2.4%) | 7 |
Syncope | 4/295 (1.4%) | 5 |
Tremor | 5/295 (1.7%) | 5 |
Trigeminal nerve disorder | 1/295 (0.3%) | 1 |
Psychiatric disorders | ||
Agitation | 4/295 (1.4%) | 5 |
Anxiety | 22/295 (7.5%) | 27 |
Confusion | 9/295 (3.1%) | 9 |
Depression | 26/295 (8.8%) | 32 |
Euphoria | 1/295 (0.3%) | 1 |
Insomnia | 41/295 (13.9%) | 45 |
Libido decreased | 1/295 (0.3%) | 1 |
Psychosis | 5/295 (1.7%) | 6 |
Renal and urinary disorders | ||
Bladder spasm | 1/295 (0.3%) | 1 |
Cystitis | 1/295 (0.3%) | 2 |
Glomerular filtration rate decreased | 1/295 (0.3%) | 1 |
Hemorrhage urinary tract | 1/295 (0.3%) | 1 |
Kidney pain | 1/295 (0.3%) | 1 |
Renal failure | 8/295 (2.7%) | 8 |
Urethral pain | 2/295 (0.7%) | 2 |
Urinary frequency | 4/295 (1.4%) | 4 |
Urinary incontinence | 3/295 (1%) | 3 |
Urine discoloration | 5/295 (1.7%) | 5 |
Urogenital disorder | 2/295 (0.7%) | 2 |
Reproductive system and breast disorders | ||
Erectile dysfunction | 1/295 (0.3%) | 1 |
Pelvic pain | 1/295 (0.3%) | 1 |
Reproductive tract disorder | 1/295 (0.3%) | 1 |
Scrotal pain | 1/295 (0.3%) | 1 |
Vaginal hemorrhage | 9/295 (3.1%) | 10 |
Respiratory, thoracic and mediastinal disorders | ||
Adult respiratory distress syndrome | 2/295 (0.7%) | 2 |
Allergic rhinitis | 10/295 (3.4%) | 11 |
Aspiration | 1/295 (0.3%) | 1 |
Atelectasis | 3/295 (1%) | 3 |
Bronchopulmonary hemorrhage | 1/295 (0.3%) | 1 |
Bronchospasm | 1/295 (0.3%) | 1 |
Cough | 32/295 (10.8%) | 38 |
Dyspnea | 30/295 (10.2%) | 34 |
Epistaxis | 15/295 (5.1%) | 16 |
Hiccups | 10/295 (3.4%) | 10 |
Hypoxia | 12/295 (4.1%) | 12 |
Laryngeal stenosis | 1/295 (0.3%) | 1 |
Nasal congestion | 2/295 (0.7%) | 2 |
Pharyngeal mucositis (clin exam) | 2/295 (0.7%) | 2 |
Pharyngolaryngeal pain | 18/295 (6.1%) | 19 |
Pleural effusion | 5/295 (1.7%) | 6 |
Pleuritic pain | 3/295 (1%) | 3 |
Pneumonitis | 7/295 (2.4%) | 7 |
Pneumothorax | 3/295 (1%) | 3 |
Respiratory disorder | 7/295 (2.4%) | 9 |
Voice alteration | 2/295 (0.7%) | 3 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 20/295 (6.8%) | 22 |
Decubitus ulcer | 1/295 (0.3%) | 1 |
Dry skin | 3/295 (1%) | 3 |
Erythema multiforme | 3/295 (1%) | 3 |
Hand-and-foot syndrome/reaction | 1/295 (0.3%) | 1 |
Nail disorder | 1/295 (0.3%) | 1 |
Petechiae | 8/295 (2.7%) | 9 |
Photosensitivity | 1/295 (0.3%) | 1 |
Pruritus | 7/295 (2.4%) | 7 |
Rash acneiform | 6/295 (2%) | 7 |
Rash desquamating | 26/295 (8.8%) | 31 |
Scalp pain | 1/295 (0.3%) | 1 |
Skin disorder | 6/295 (2%) | 6 |
Skin hyperpigmentation | 1/295 (0.3%) | 1 |
Skin hypopigmentation | 1/295 (0.3%) | 1 |
Skin induration | 1/295 (0.3%) | 1 |
Skin striae | 1/295 (0.3%) | 1 |
Skin ulceration | 6/295 (2%) | 6 |
Sweating | 15/295 (5.1%) | 15 |
Urticaria | 4/295 (1.4%) | 5 |
Vascular disorders | ||
Flushing | 1/295 (0.3%) | 1 |
Hematoma | 6/295 (2%) | 6 |
Hemorrhage | 3/295 (1%) | 4 |
Hypertension | 10/295 (3.4%) | 12 |
Hypotension | 21/295 (7.1%) | 23 |
Thrombosis | 23/295 (7.8%) | 26 |
Vascular disorder | 2/295 (0.7%) | 2 |
Other (Not Including Serious) Adverse Events |
||
Treatment (Pediatric Regimen) | ||
Affected / at Risk (%) | # Events | |
Total | 268/295 (90.8%) | |
Blood and lymphatic system disorders | ||
Blood disorder | 10/295 (3.4%) | 10 |
Bone marrow hypocellular | 1/295 (0.3%) | 2 |
Disseminated intravascular coagulation | 13/295 (4.4%) | 14 |
Febrile neutropenia | 114/295 (38.6%) | 181 |
Hemoglobin decreased | 259/295 (87.8%) | 1235 |
Hemolysis | 2/295 (0.7%) | 2 |
Lymphatic disorder | 5/295 (1.7%) | 5 |
Thrombotic microangiopathy | 1/295 (0.3%) | 1 |
Cardiac disorders | ||
Arrhythmia | 4/295 (1.4%) | 4 |
Atrial fibrillation | 2/295 (0.7%) | 2 |
Atrial tachycardia | 7/295 (2.4%) | 7 |
Cardiac disorder | 6/295 (2%) | 7 |
Cardiac pain | 2/295 (0.7%) | 2 |
Edema | 1/295 (0.3%) | 1 |
Left ventricular failure | 3/295 (1%) | 3 |
Palpitations | 22/295 (7.5%) | 29 |
Pericardial effusion | 8/295 (2.7%) | 8 |
Pericarditis | 2/295 (0.7%) | 2 |
Premature ventricular contractions | 1/295 (0.3%) | 1 |
Sinus arrhythmia | 1/295 (0.3%) | 1 |
Sinus bradycardia | 9/295 (3.1%) | 10 |
Sinus tachycardia | 66/295 (22.4%) | 120 |
Supraventricular tachycardia | 6/295 (2%) | 7 |
Ventricular bigeminy | 1/295 (0.3%) | 1 |
Ventricular tachycardia | 8/295 (2.7%) | 13 |
Ear and labyrinth disorders | ||
Ear disorder | 9/295 (3.1%) | 9 |
Ear pain | 16/295 (5.4%) | 19 |
External ear inflammation | 2/295 (0.7%) | 2 |
External ear pain | 7/295 (2.4%) | 7 |
Hearing impaired | 5/295 (1.7%) | 7 |
Middle ear inflammation | 3/295 (1%) | 3 |
Tinnitus | 7/295 (2.4%) | 7 |
Endocrine disorders | ||
Cushingoid | 14/295 (4.7%) | 28 |
Endocrine disorder | 1/295 (0.3%) | 1 |
Hypothyroidism | 3/295 (1%) | 4 |
Eye disorders | ||
Diplopia | 4/295 (1.4%) | 4 |
Dry eye syndrome | 9/295 (3.1%) | 11 |
Extraocular muscle paresis | 7/295 (2.4%) | 9 |
Eye disorder | 28/295 (9.5%) | 36 |
Eye pain | 9/295 (3.1%) | 9 |
Eyelid function disorder | 2/295 (0.7%) | 3 |
Flashing vision | 4/295 (1.4%) | 4 |
Photophobia | 14/295 (4.7%) | 15 |
Retinopathy | 1/295 (0.3%) | 2 |
Vision blurred | 43/295 (14.6%) | 57 |
Vitreous hemorrhage | 1/295 (0.3%) | 1 |
Watering eyes | 4/295 (1.4%) | 4 |
Gastrointestinal disorders | ||
Abdominal distension | 32/295 (10.8%) | 35 |
Abdominal pain | 105/295 (35.6%) | 185 |
Anal hemorrhage | 1/295 (0.3%) | 1 |
Anal pain | 2/295 (0.7%) | 2 |
Ascites | 5/295 (1.7%) | 10 |
Colitis | 9/295 (3.1%) | 9 |
Colonic perforation | 1/295 (0.3%) | 1 |
Constipation | 141/295 (47.8%) | 290 |
Diarrhea | 127/295 (43.1%) | 257 |
Dry mouth | 13/295 (4.4%) | 24 |
Dyspepsia | 64/295 (21.7%) | 113 |
Dysphagia | 13/295 (4.4%) | 15 |
Enteritis | 1/295 (0.3%) | 1 |
Esophageal mucositis (clin exam) | 1/295 (0.3%) | 1 |
Esophageal mucositis (funct/sympt) | 3/295 (1%) | 3 |
Esophageal pain | 7/295 (2.4%) | 7 |
Esophageal ulcer | 1/295 (0.3%) | 1 |
Fecal incontinence | 6/295 (2%) | 8 |
Flatulence | 12/295 (4.1%) | 13 |
Gastric ulcer | 1/295 (0.3%) | 1 |
Gastritis | 13/295 (4.4%) | 15 |
Gastrointestinal disorder | 35/295 (11.9%) | 82 |
Gingival pain | 10/295 (3.4%) | 11 |
Hemorrhoidal hemorrhage | 1/295 (0.3%) | 1 |
Hemorrhoids | 17/295 (5.8%) | 22 |
Ileus | 3/295 (1%) | 3 |
Intra-abdominal hemorrhage | 1/295 (0.3%) | 1 |
Lip pain | 2/295 (0.7%) | 2 |
Lower gastrointestinal hemorrhage | 3/295 (1%) | 3 |
Malabsorption | 2/295 (0.7%) | 2 |
Melena/GI bleeding | 1/295 (0.3%) | 1 |
Mucositis oral (clin exam) | 86/295 (29.2%) | 133 |
Nausea | 221/295 (74.9%) | 724 |
Oral hemorrhage | 14/295 (4.7%) | 18 |
Oral pain | 22/295 (7.5%) | 24 |
Pancreatitis | 24/295 (8.1%) | 30 |
Periodontal disease | 2/295 (0.7%) | 4 |
Rectal hemorrhage | 15/295 (5.1%) | 23 |
Rectal mucositis (clin exam) | 1/295 (0.3%) | 1 |
Rectal mucositis (funct/sympt) | 1/295 (0.3%) | 1 |
Rectal pain | 8/295 (2.7%) | 8 |
Rectal ulcer | 1/295 (0.3%) | 1 |
Salivary gland disorder | 1/295 (0.3%) | 1 |
Salivary gland fistula | 1/295 (0.3%) | 1 |
Small intestinal mucositis (funct/sympt) | 1/295 (0.3%) | 1 |
Small intestinal stenosis | 1/295 (0.3%) | 1 |
Stomach pain | 16/295 (5.4%) | 20 |
Tooth development disorder | 1/295 (0.3%) | 1 |
Tooth disorder | 6/295 (2%) | 14 |
Toothache | 15/295 (5.1%) | 18 |
Typhlitis | 4/295 (1.4%) | 4 |
Upper gastrointestinal hemorrhage | 3/295 (1%) | 3 |
Vomiting | 172/295 (58.3%) | 405 |
General disorders | ||
Chest pain | 40/295 (13.6%) | 53 |
Chills | 56/295 (19%) | 77 |
Edema limbs | 83/295 (28.1%) | 149 |
Facial pain | 6/295 (2%) | 6 |
Fatigue | 214/295 (72.5%) | 733 |
Fever | 80/295 (27.1%) | 110 |
Flu-like symptoms | 12/295 (4.1%) | 12 |
Gait abnormal | 4/295 (1.4%) | 4 |
General symptom | 22/295 (7.5%) | 29 |
Hypothermia | 1/295 (0.3%) | 1 |
Ill-defined disorder | 4/295 (1.4%) | 5 |
Injection site reaction | 7/295 (2.4%) | 8 |
Localized edema | 28/295 (9.5%) | 45 |
Pain | 68/295 (23.1%) | 106 |
Visceral edema | 1/295 (0.3%) | 1 |
Hepatobiliary disorders | ||
Cholecystitis | 3/295 (1%) | 3 |
Hepatic failure | 6/295 (2%) | 6 |
Hepatic pain | 1/295 (0.3%) | 1 |
Hepatobiliary disease | 7/295 (2.4%) | 14 |
Immune system disorders | ||
Cytokine release syndrome | 6/295 (2%) | 10 |
Hypersensitivity | 34/295 (11.5%) | 37 |
Immune system disorder | 5/295 (1.7%) | 8 |
Serum sickness | 1/295 (0.3%) | 1 |
Infections and infestations | ||
Appendicitis perforated | 1/295 (0.3%) | 1 |
Colitis, infectious | 11/295 (3.7%) | 15 |
Conjunctivitis | 1/295 (0.3%) | 2 |
Opportunistic infection | 3/295 (1%) | 3 |
Urinary tract infection(gr 0/1/2 ANC) | 161/295 (54.6%) | 265 |
Viral hepatitis | 1/295 (0.3%) | 1 |
Injury, poisoning and procedural complications | ||
Bruising | 39/295 (13.2%) | 62 |
Device complication | 1/295 (0.3%) | 1 |
Intraoperative complications | 1/295 (0.3%) | 1 |
Pancreatic anastomotic leak | 1/295 (0.3%) | 1 |
Thermal burn | 3/295 (1%) | 3 |
Wound dehiscence | 4/295 (1.4%) | 4 |
Investigations | ||
ADH abnormal | 1/295 (0.3%) | 1 |
Activated partial throm time prolonged | 69/295 (23.4%) | 179 |
Alanine aminotransferase increased | 247/295 (83.7%) | 1359 |
Alkaline phosphatase increased | 117/295 (39.7%) | 308 |
Amylase increased | 25/295 (8.5%) | 29 |
Aspartate aminotransferase increased | 240/295 (81.4%) | 1107 |
Blood bilirubin increased | 206/295 (69.8%) | 673 |
CD4 lymphocytes decreased | 2/295 (0.7%) | 6 |
Coagulopathy | 11/295 (3.7%) | 14 |
Creatine phosphokinase increased | 1/295 (0.3%) | 1 |
Creatinine increased | 71/295 (24.1%) | 101 |
Electrocardiogram QTc interval prolonged | 4/295 (1.4%) | 4 |
Fibrinogen decreased | 166/295 (56.3%) | 289 |
Gamma-glutamyltransferase increased | 22/295 (7.5%) | 59 |
Haptoglobin decreased | 1/295 (0.3%) | 2 |
INR increased | 49/295 (16.6%) | 112 |
Laboratory test abnormal | 33/295 (11.2%) | 74 |
Leukocyte count decreased | 162/295 (54.9%) | 793 |
Lipase increased | 45/295 (15.3%) | 60 |
Lymphocyte count decreased | 116/295 (39.3%) | 600 |
Neutrophil count decreased | 256/295 (86.8%) | 1240 |
Platelet count decreased | 255/295 (86.4%) | 1151 |
Serum cholesterol increased | 20/295 (6.8%) | 41 |
Weight gain | 27/295 (9.2%) | 61 |
Weight loss | 57/295 (19.3%) | 95 |
Metabolism and nutrition disorders | ||
Acidosis | 3/295 (1%) | 3 |
Anorexia | 117/295 (39.7%) | 237 |
Blood bicarbonate decreased | 16/295 (5.4%) | 36 |
Blood glucose increased | 232/295 (78.6%) | 1019 |
Blood uric acid increased | 29/295 (9.8%) | 55 |
Dehydration | 37/295 (12.5%) | 45 |
Glucose intolerance | 4/295 (1.4%) | 4 |
Iron overload | 3/295 (1%) | 6 |
Obesity | 2/295 (0.7%) | 3 |
Serum albumin decreased | 142/295 (48.1%) | 344 |
Serum calcium decreased | 129/295 (43.7%) | 311 |
Serum calcium increased | 14/295 (4.7%) | 21 |
Serum glucose decreased | 65/295 (22%) | 125 |
Serum magnesium decreased | 61/295 (20.7%) | 123 |
Serum magnesium increased | 34/295 (11.5%) | 45 |
Serum phosphate decreased | 50/295 (16.9%) | 75 |
Serum potassium decreased | 130/295 (44.1%) | 267 |
Serum potassium increased | 40/295 (13.6%) | 48 |
Serum sodium decreased | 136/295 (46.1%) | 296 |
Serum sodium increased | 23/295 (7.8%) | 37 |
Serum triglycerides increased | 31/295 (10.5%) | 58 |
Tumor lysis syndrome | 14/295 (4.7%) | 14 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 82/295 (27.8%) | 188 |
Arthritis | 2/295 (0.7%) | 2 |
Back pain | 127/295 (43.1%) | 297 |
Buttock pain | 2/295 (0.7%) | 2 |
Chest wall pain | 17/295 (5.8%) | 22 |
Exostosis | 1/295 (0.3%) | 1 |
Joint disorder | 4/295 (1.4%) | 7 |
Joint range motion decr cervical spine | 1/295 (0.3%) | 1 |
Muscle weakness | 53/295 (18%) | 98 |
Muscle weakness lower limb | 35/295 (11.9%) | 55 |
Muscle weakness trunk | 1/295 (0.3%) | 1 |
Muscle weakness upper limb | 4/295 (1.4%) | 5 |
Myalgia | 68/295 (23.1%) | 162 |
Myositis | 2/295 (0.7%) | 5 |
Neck pain | 33/295 (11.2%) | 48 |
Osteonecrosis | 76/295 (25.8%) | 96 |
Osteoporosis | 9/295 (3.1%) | 22 |
Pain in extremity | 104/295 (35.3%) | 224 |
Slipped femoral epiphysis | 1/295 (0.3%) | 1 |
Soft tissue necrosis lower limb | 1/295 (0.3%) | 1 |
Upper extremity dysfunction | 1/295 (0.3%) | 1 |
Nervous system disorders | ||
Acoustic nerve disorder NOS | 1/295 (0.3%) | 1 |
Arachnoiditis | 2/295 (0.7%) | 2 |
Ataxia | 4/295 (1.4%) | 4 |
Cerebrospinal fluid leakage | 8/295 (2.7%) | 8 |
Cognitive disturbance | 7/295 (2.4%) | 7 |
Depressed level of consciousness | 3/295 (1%) | 3 |
Dizziness | 89/295 (30.2%) | 169 |
Dysgeusia | 34/295 (11.5%) | 46 |
Extrapyramidal disorder | 4/295 (1.4%) | 4 |
Facial nerve disorder | 1/295 (0.3%) | 1 |
Glossopharyngeal nerve disorder | 1/295 (0.3%) | 1 |
Headache | 199/295 (67.5%) | 607 |
Intracranial hemorrhage | 6/295 (2%) | 6 |
Ischemia cerebrovascular | 2/295 (0.7%) | 2 |
Leukoencephalopathy | 2/295 (0.7%) | 2 |
Memory impairment | 12/295 (4.1%) | 29 |
Mini mental status examination abnormal | 3/295 (1%) | 3 |
Neuralgia | 7/295 (2.4%) | 13 |
Neurological disorder NOS | 21/295 (7.1%) | 23 |
Peripheral motor neuropathy | 35/295 (11.9%) | 84 |
Peripheral sensory neuropathy | 202/295 (68.5%) | 891 |
Seizure | 9/295 (3.1%) | 11 |
Speech disorder | 5/295 (1.7%) | 6 |
Syncope | 6/295 (2%) | 6 |
Syncope vasovagal | 3/295 (1%) | 3 |
Tremor | 16/295 (5.4%) | 25 |
Psychiatric disorders | ||
Agitation | 11/295 (3.7%) | 15 |
Anxiety | 98/295 (33.2%) | 194 |
Confusion | 13/295 (4.4%) | 14 |
Depression | 76/295 (25.8%) | 168 |
Euphoria | 1/295 (0.3%) | 1 |
Insomnia | 123/295 (41.7%) | 236 |
Libido decreased | 4/295 (1.4%) | 5 |
Personality change | 1/295 (0.3%) | 1 |
Psychosis | 6/295 (2%) | 6 |
Renal and urinary disorders | ||
Bladder hemorrhage | 3/295 (1%) | 3 |
Bladder pain | 3/295 (1%) | 3 |
Bladder spasm | 2/295 (0.7%) | 3 |
Cystitis | 1/295 (0.3%) | 1 |
Hemoglobin urine positive | 1/295 (0.3%) | 1 |
Hemorrhage urinary tract | 6/295 (2%) | 6 |
Kidney pain | 3/295 (1%) | 3 |
Proteinuria | 2/295 (0.7%) | 2 |
Renal failure | 1/295 (0.3%) | 1 |
Urethral obstruction | 1/295 (0.3%) | 1 |
Urethral pain | 3/295 (1%) | 3 |
Urethral stenosis | 1/295 (0.3%) | 1 |
Urinary frequency | 23/295 (7.8%) | 31 |
Urinary incontinence | 9/295 (3.1%) | 15 |
Urinary retention | 8/295 (2.7%) | 11 |
Urine discoloration | 9/295 (3.1%) | 9 |
Urogenital disorder | 20/295 (6.8%) | 33 |
Reproductive system and breast disorders | ||
Breast pain | 3/295 (1%) | 3 |
Erectile dysfunction | 5/295 (1.7%) | 6 |
Gynecomastia | 1/295 (0.3%) | 1 |
Irregular menstruation | 5/295 (1.7%) | 6 |
Ovarian hemorrhage | 1/295 (0.3%) | 2 |
Pelvic floor muscle weakness | 1/295 (0.3%) | 1 |
Pelvic pain | 4/295 (1.4%) | 6 |
Perineal pain | 1/295 (0.3%) | 1 |
Reproductive tract disorder | 1/295 (0.3%) | 1 |
Scrotal pain | 4/295 (1.4%) | 5 |
Testicular pain | 2/295 (0.7%) | 2 |
Uterine hemorrhage | 2/295 (0.7%) | 6 |
Uterine pain | 1/295 (0.3%) | 1 |
Vaginal discharge | 2/295 (0.7%) | 2 |
Vaginal hemorrhage | 20/295 (6.8%) | 25 |
Vaginal pain | 2/295 (0.7%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||
Allergic rhinitis | 59/295 (20%) | 93 |
Atelectasis | 4/295 (1.4%) | 4 |
Bronchopulmonary hemorrhage | 1/295 (0.3%) | 1 |
Bronchospasm | 6/295 (2%) | 8 |
Cough | 116/295 (39.3%) | 256 |
Dyspnea | 87/295 (29.5%) | 172 |
Epistaxis | 50/295 (16.9%) | 67 |
Hiccups | 15/295 (5.1%) | 21 |
Hypoxia | 8/295 (2.7%) | 8 |
Laryngeal fistula | 1/295 (0.3%) | 1 |
Laryngeal mucositis (clin exam) | 2/295 (0.7%) | 2 |
Nasal congestion | 14/295 (4.7%) | 17 |
Pharyngeal hemorrhage | 1/295 (0.3%) | 1 |
Pharyngeal mucositis (clin exam) | 4/295 (1.4%) | 4 |
Pharyngeal mucositis (funct/sympt) | 1/295 (0.3%) | 2 |
Pharyngolaryngeal pain | 46/295 (15.6%) | 64 |
Pleural effusion | 14/295 (4.7%) | 17 |
Pleuritic pain | 6/295 (2%) | 7 |
Pneumonitis | 4/295 (1.4%) | 5 |
Pneumothorax | 1/295 (0.3%) | 1 |
Pulmonary fibrosis | 1/295 (0.3%) | 1 |
Respiratory disorder | 28/295 (9.5%) | 42 |
Respiratory tract hemorrhage | 2/295 (0.7%) | 2 |
Sinus pain | 9/295 (3.1%) | 10 |
Tracheal mucositis (funct/sympt) | 1/295 (0.3%) | 1 |
Voice alteration | 7/295 (2.4%) | 10 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 75/295 (25.4%) | 155 |
Decubitus ulcer | 6/295 (2%) | 9 |
Dry skin | 17/295 (5.8%) | 22 |
Erythema multiforme | 4/295 (1.4%) | 5 |
Hand-and-foot syndrome/reaction | 8/295 (2.7%) | 11 |
Nail disorder | 7/295 (2.4%) | 13 |
Pain of skin | 3/295 (1%) | 3 |
Petechiae | 24/295 (8.1%) | 32 |
Photosensitivity | 2/295 (0.7%) | 2 |
Pruritus | 38/295 (12.9%) | 48 |
Rash acneiform | 30/295 (10.2%) | 56 |
Rash desquamating | 95/295 (32.2%) | 180 |
Scalp pain | 2/295 (0.7%) | 3 |
Skin atrophy | 1/295 (0.3%) | 1 |
Skin disorder | 37/295 (12.5%) | 68 |
Skin hyperpigmentation | 3/295 (1%) | 4 |
Skin induration | 1/295 (0.3%) | 1 |
Skin striae | 4/295 (1.4%) | 4 |
Skin ulceration | 11/295 (3.7%) | 14 |
Sweating | 57/295 (19.3%) | 91 |
Urticaria | 9/295 (3.1%) | 9 |
Vascular disorders | ||
Flushing | 6/295 (2%) | 7 |
Hematoma | 13/295 (4.4%) | 16 |
Hemorrhage | 14/295 (4.7%) | 15 |
Hot flashes | 15/295 (5.1%) | 23 |
Hypertension | 38/295 (12.9%) | 82 |
Hypotension | 55/295 (18.6%) | 75 |
Lymphedema | 2/295 (0.7%) | 3 |
Phlebitis | 3/295 (1%) | 4 |
Thrombosis | 43/295 (14.6%) | 53 |
Vascular disorder | 3/295 (1%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Wendy Stock, MD |
---|---|
Organization | University of Chicago |
Phone | 773-834-8982 |
wstock@medicine.bsd.uchicago.edu |
- CALGB-10403
- CALGB-10403
- ECOG C10403
- CDR0000574230