Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00558519
Collaborator
National Cancer Institute (NCI) (NIH)
318
1

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
  1. 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

Study Type:
Interventional
Actual Enrollment :
318 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date :
Mar 12, 2008
Actual Primary Completion Date :
Sep 1, 2016

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

  1. 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.

  2. 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.

  3. 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.

  4. Overall Survival [Up to 8 years post-registration]

    OS was defined from registration to death resulting from any cause.

  5. 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

  1. 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]

  2. 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]

  3. 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]

  4. 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

Ages Eligible for Study:
16 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Eligibility Criteria:
  1. Diagnosis

  2. 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.

  3. 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.

  1. Age: 16 - 39 years

  2. ECOG Performance Status 0-2

  3. 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.

  4. Prior Therapy - No prior therapy except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.

  5. 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.

  6. 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.

  7. 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

Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00558519
Other Study ID Numbers:
  • CALGB-10403
  • CALGB-10403
  • ECOG C10403
  • CDR0000574230
First Posted:
Nov 15, 2007
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021

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

1. Primary Outcome
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
2. Primary Outcome
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
3. Primary Outcome
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
4. Primary Outcome
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
5. Primary Outcome
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%
6. Other Pre-specified Outcome
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
7. Other Pre-specified Outcome
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
8. Other Pre-specified Outcome
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
9. Other Pre-specified Outcome
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

[Not Specified]

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
Email wstock@medicine.bsd.uchicago.edu
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00558519
Other Study ID Numbers:
  • CALGB-10403
  • CALGB-10403
  • ECOG C10403
  • CDR0000574230
First Posted:
Nov 15, 2007
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021