Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| COG-ACCL0431 | Other Identifier | Children's Oncology Group | |
| CDR0000588655 | Other Identifier | Clinical Trials.gov |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss.
PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior cranial radiation (yes vs no), age (< 5 years vs ≥ 5 years) and duration of cisplatin infusion (< 2 hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms.
Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment. Some patients may undergo saliva collection for DNA studies.
After completion of study, patients are followed periodically for 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STS Arm (sodium thiosulfate treatment) | Experimental | Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy. |
|
| Observation Arm (No sodium thiosulfate treatment) | Experimental | Patients do not receive sodium thiosulfate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium thiosulfate | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hearing Loss | Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria. | 4 weeks after last dose of cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing Thresholds For Key Frequencies at 500 hz | Mean change in hearing threshold (post-pre) at 500 hz. | 4 weeks after last dose of cisplatin |
| Change in Hearing Thresholds For Key Frequencies at 1000 hz |
Not provided
DISEASE CHARACTERISTICS:
Newly diagnosed (previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study) with germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy
Planning to receive a chemotherapy treatment regimen that includes a cumulative cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6 hours
Enrolled on hearing assessment clinical trial COG-ACCL05C1
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior platinum-based chemotherapy (cisplatin or carboplatin)
Prior cranial radiotherapy (e.g., for treatment of medulloblastoma) allowed provided normal hearing is documented after completion of radiotherapy and before enrollment and administration of cisplatin chemotherapy
At least 6 months since prior hematopoietic stem cell transplantation.
No concurrent enrollment on another COG clinical trial for treatment of the cancer.
Cranial irradiation after the completion of all systemic chemotherapy allowed provided post end-of-treatment audiometry is completed prior to beginning irradiation.
Concurrent radiotherapy to extracranial sites allowed.
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| Name | Affiliation | Role |
|---|---|---|
| David R. Freyer, DO, MS | Children's Hospital Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27914822 | Derived | Freyer DR, Chen L, Krailo MD, Knight K, Villaluna D, Bliss B, Pollock BH, Ramdas J, Lange B, Van Hoff D, VanSoelen ML, Wiernikowski J, Neuwelt EA, Sung L. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jan;18(1):63-74. doi: 10.1016/S1470-2045(16)30625-8. Epub 2016 Dec 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | STS Arm (Sodium Thiosulfate Treatment) | Sodium thiosulfate treatment. |
| FG001 | Observation Arm | No sodium thiosulfate treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| examination | Procedure | Patients undergo audiological assessments periodically |
|
Mean change in hearing threshold (post-pre) at 1000 hz.
| 4 weeks after last dose of cisplatin |
| Change in Hearing Thresholds For Key Frequencies at 2000 hz | Mean change in hearing threshold (post-pre) at 2000 hz | 4 weeks after last dose of cisplatin |
| Change in Hearing Thresholds For Key Frequencies at 4000 hz | Mean change in hearing threshold (post-pre) at 4000 hz. | 4 weeks after last dose of cisplatin |
| Change in Hearing Thresholds For Key Frequencies at 8000 hz | Mean change in hearing threshold (post-pre) at 8000 hz. | 4 weeks after last dose of cisplatin |
| Event-Free Survival (EFS) | Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description. | 4 years after enrollment |
| Overall Survival (OS) | Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description. | 4 Years after enrollment |
| Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT) | 4 weeks after the last dose of cisplatin |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | United States |
| Children's Hospital Central California | Madera | California | 93638-8762 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123-4282 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | United States |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | 83712-6297 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61603 | United States |
| Riley's Children Cancer Center at Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| Children's Hospital of New Orleans | New Orleans | Louisiana | 70118 | United States |
| National Naval Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007-5381 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89109-2306 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106-5000 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99220-2555 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Children's and Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3J 3G9 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | G1V 4G2 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | STS Arm (Sodium Thiosulfate Treatment) | Sodium thiosulfate treatment. |
| BG001 | Observation Arm | No sodium thiosulfate treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 1 patient of unknown origin in STS arm | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Hearing Loss | Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria. | 55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation. | Posted | Number | Patients | 4 weeks after last dose of cisplatin |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Hearing Thresholds For Key Frequencies at 500 hz | Mean change in hearing threshold (post-pre) at 500 hz. | 38 eligible patients in the STS arm had paired audiometry at 500 hz; 45 patients in the observation arm had paired audiometry at 500 hz. | Posted | Mean | Standard Deviation | Decibels | 4 weeks after last dose of cisplatin |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Hearing Thresholds For Key Frequencies at 1000 hz | Mean change in hearing threshold (post-pre) at 1000 hz. | 37 eligible patients in the STS arm had paired audiometry at 1000 hz; 47 patients in the observation arm had paired audiometry at 1000 hz. | Posted | Mean | Standard Deviation | Decibels | 4 weeks after last dose of cisplatin |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Hearing Thresholds For Key Frequencies at 2000 hz | Mean change in hearing threshold (post-pre) at 2000 hz | 38 eligible patients in the STS arm had paired audiometry at 2000 hz; 47 patients in the observation arm had paired audiometry at 2000 hz. | Posted | Mean | Standard Deviation | Decibels | 4 weeks after last dose of cisplatin |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Hearing Thresholds For Key Frequencies at 4000 hz | Mean change in hearing threshold (post-pre) at 4000 hz. | 38 eligible patients in the STS arm had paired audiometry at 4000 hz; 47 patients in the observation arm had paired audiometry at 4000 hz. | Posted | Mean | Standard Deviation | Decibels | 4 weeks after last dose of cisplatin |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Hearing Thresholds For Key Frequencies at 8000 hz | Mean change in hearing threshold (post-pre) at 8000 hz. | 38 eligible patients in the STS arm had paired audiometry at 8000 hz; 42 patients in the observation arm had paired audiometry at 8000 hz. | Posted | Mean | Standard Deviation | Decibels | 4 weeks after last dose of cisplatin |
|
| |||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) | Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description. | 61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm. | Posted | Number | 95% Confidence Interval | Percentage probability | 4 years after enrollment |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description. | 61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm. | Posted | Number | 95% Confidence Interval | Percentage probability | 4 Years after enrollment |
|
| |||||||||||||||||||||||||||||
| Secondary | Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT) | Data was and never will be collected | Posted | 4 weeks after the last dose of cisplatin |
|
|
Not provided
Serious Adverse Events were reported on this study via the NCI AERS reporting system. Per protocol, no expedited reports were submitted for patients on Observation only arm of the study. Thus, no patients enrolled on the Observation arm of the trial were at risk for having a Serious Adverse Event reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STS Arm (Sodium Thiosulfate Treatment) | 21 | 59 | 51 | 59 | |||
| EG001 | Observation Arm | 0 | 0 | 57 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal infection | Infections and infestations |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Acidosis | Metabolism and nutrition disorders |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Anaphylaxis | Immune system disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Cardiac arrest | Cardiac disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Conjunctivitis | Eye disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Depressed level of consciousness | Nervous system disorders |
| |||
| Extrapyramidal disorder | Nervous system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Infections and infestations - Other, specify | Infections and infestations |
| |||
| Lymphocyte count decreased | Investigations |
| |||
| Mucositis oral | Gastrointestinal disorders |
| |||
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Neutrophil count decreased | Investigations |
| |||
| Oral pain | Gastrointestinal disorders |
| |||
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders |
| |||
| Platelet count decreased | Investigations |
| |||
| Rectal pain | Gastrointestinal disorders |
| |||
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Typhlitis | Gastrointestinal disorders |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Weight loss | Investigations |
| |||
| White blood cell decreased | Investigations |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal infection | Infections and infestations |
| |||
| Acidosis | Metabolism and nutrition disorders |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Allergic reaction | Immune system disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Blood bilirubin increased | Investigations |
| |||
| Bone infection | Infections and infestations |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Catheter related infection | Infections and infestations |
| |||
| Chills | General disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Confusion | Psychiatric disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Device related infection | Infections and infestations |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Enterocolitis infectious | Infections and infestations |
| |||
| Esophageal infection | Infections and infestations |
| |||
| Esophageal pain | Gastrointestinal disorders |
| |||
| Esophageal ulcer | Gastrointestinal disorders |
| |||
| Esophagitis | Gastrointestinal disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| GGT increased | Investigations |
| |||
| Hearing impaired | Ear and labyrinth disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Hypermagnesemia | Metabolism and nutrition disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Infections and infestations - Other, specify | Infections and infestations |
| |||
| Infusion related reaction | General disorders |
| |||
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders |
| |||
| Leukoencephalopathy | Nervous system disorders |
| |||
| Lymphocyte count decreased | Investigations |
| |||
| Middle ear inflammation | Ear and labyrinth disorders |
| |||
| Mucositis oral | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Neutrophil count decreased | Investigations |
| |||
| Otitis media | Infections and infestations |
| |||
| Pain | General disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Paronychia | Infections and infestations |
| |||
| Penile infection | Infections and infestations |
| |||
| Perineal pain | Reproductive system and breast disorders |
| |||
| Peripheral motor neuropathy | Nervous system disorders |
| |||
| Peripheral sensory neuropathy | Nervous system disorders |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Platelet count decreased | Investigations |
| |||
| Sepsis | Infections and infestations |
| |||
| Sinusitis | Infections and infestations |
| |||
| Skin infection | Infections and infestations |
| |||
| Skin ulceration | Skin and subcutaneous tissue disorders |
| |||
| Upper respiratory infection | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Weight loss | Investigations |
| |||
| White blood cell decreased | Investigations |
| |||
| Wound infection | Infections and infestations |
|
Data was and never will be collected for Outcome Measure #9, Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT).
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D008113 | Liver Neoplasms |
| D009447 | Neuroblastoma |
| D000081015 | Ototoxicity |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D013736 | Testicular Neoplasms |
| C562841 | Ovarian Germ Cell Cancer |
| D013724 | Teratoma |
| D008527 | Medulloblastoma |
| D012516 | Osteosarcoma |
| D018197 | Hepatoblastoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
| D005910 | Glioma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018193 | Neoplasms, Complex and Mixed |
Not provided
Not provided
| ID | Term |
|---|---|
| C017717 | sodium thiosulfate |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| United States |
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