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| ID | Type | Description | Link |
|---|---|---|---|
| NANT-2007-01 | Other Identifier | NANT Consortium |
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RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG.
PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients complete a quality of life questionnaire at baseline and then at day 60.
After completion of study treatment, patients are followed at day 60 and periodically thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultratrace™ Iobenguane I 131 | Experimental | Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. As per protocol, therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Actual doses administered ranged from 8.8 to 18.6 mCi/kg. Based on actual doses administered, patients were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltratraceTM Iobenguane I 131 Imaging | Drug | 0.1 mCi/kg [3.7 MBq/kg] (minimum dose 1mCi [37MBq] but not to exceed 5 mCi [185 MBq]) of UltratraceTM Iobenguane I 131 given 7 -28 days before therapeutic dose administration on day 0. Thyroid protection will be administered per institutional protocol for I-131-MIBG however, thyroid blocking must be started prior to the Ultratrace imaging dose. Anterior and posterior whole body images will be taken to assess organ distribution, tumor uptake and dosimetry calculations. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | The maximum tolerated dose (MTD) was defined as the dose immediately below the level at which dose escalation would be stopped due to dose limiting toxicities (DLTs). Once the MTD was reached, an additional 3 patients were to be treated at that dose level, for a total of 6 patients at that planned dose level. DLTs were defined as any of the events that are possibly, probably or definitely attributable to UltratraceTM iobenguane I 131. The MTD was supposed to be the highest dose tested at which fewer than 1/3 of pts experience a DLT when 6 patients have been treated at the MTD but the dosimetry results indicated that the maximal dosage allowed to normal organs would be exceeded if the highest planned dose (21.0 mCi/kg) was administered, so the highest dose administered in the study was 18.6 mCi/kg . | Day 60 +/-10 or Engraftment, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | Dose limiting toxicities include treatment emergent adverse events (TEAEs) that were possibly, probably, or definitely related to Ultratrace™ Iobenguane I 131. | From the time of signed informed consent until Day 60 or until the end of therapy evaluation is completed (whichever comes first). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine K. Matthay, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Lucile Packard Children's Hospital at Stanford University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultratrace™ Iobenguane I 131 | Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 within 7 days (d) of enrollment, followed by 3 dosimetry scans over 3-6 days. For the imaging dose, 0.1 mCi/kg (3.7 MBq/kg), at a min dose of 1 mCi (37 MBq) but not to exceed 5 mCi (185 MBq) of Ultratrace™ Iobenguane I 131 was administered 7-28 d prior to the therapeutic dose on Day 0. If the imaging dose demonstrated NL biodistribution/tumor uptake, pts received a therapeutic dose within 7-28 d of the imaging dose followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Based on actual doses administered, pts were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg. The dosimetry dose was administered over 1-3 mins by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused over 30 to 60 mins. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Ultratrace™ Iobenguane I 131
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| UltratraceTM Iobenguane I 131 Therapy | Drug | Therapeutic dose will be given on Day 0 if dosimetry scans showed that the prescribed or adjusted dose will not exceed > 23 Gy to the kidneys, > 30 Gy to the liver, or > 15 Gy to the lungs. and tumor uptake confirmed with UltratraceTM imaging dose. Only one treatment course of therapeutic UltratraceTM will be given in this study. |
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| Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions |
The dosimetric endpoint was to estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following an imaging dose of 0.1 mCi/kg Ultratrace™ Iobenguane I 131. Biodistribution was assessed by determination of total body residence (TBR) time and by visual examination of whole body camera images. 3 timepoints were used, the 1st image was taken within 1hr after the imaging dose, the 2nd image was taken at ~24hr after imaging dose, the 3rd image was taken 2-5d after imaging dose. Whole body radiation absorbed dose estimates & kidney, liver, and lung were calculated using the Medical Internal Radiation Dose (MIRD) schema.TBR time is derived from time integration of curve-fitted injected activity across all 3 timepoints when the isotope is emitting radiation.Three points are sampled to estimate a singular value for each organ and tissue according to the commonly used methods of the Society of Nuclear Medicine and Molecular Imaging Committee on MIRD. |
| Day 5 post Dosimetric Dose |
| Overall Objective Tumor Response Post Therapeutic Treatment | The International Neuroblastoma Response Criteria (INRC) were utilized as a basis for the overall response criteria, which incorporated responses in MIBG positive lesions,bone marrow disease, and CT/MRI lesions that met NANT-modified RECIST criteria. Efficacy success was defined as the proportion of pts who were successful overall [i.e., achieving a Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)] determined by independent reviewers. CR = Disappearance of all target lesions, homovanillic acid/ vanillylmandelic acid (HVA/VMA) normal (NL); VGPR = > 90% decr of disease for CT/MRI target lesions, all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD/CR in soft tissue lesions. CR in bone marrow, no new tumor sites, and NL HVA/VMA.; PR = At least 30% decr in disease measurement for CT/MRI target lesions. Bone marrow with CR, MIBG with either PR/CR in bone lesions, MIBG may be SD /CR in soft tissue lesions, and HVA/VMA may still be elevated. | Day 60 +/- 10 days post Therapeutic Dose |
| Tumor Response in CT/MRI Lesions Post Therapeutic Treatment | Measurable disease was defined for a conventional CT scan by the presence of at least one lesion that could be accurately measured in at least one dimension with the longest diameter at least 20 mm by Independent Review. Efficacy success was defined as a patient achieving a Complete Response (CR)=disappearance of all target and non-target CT/MRI lesions; or, Very Good Partial Response (VGPR)=greater than 90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurement disease at study entry. Non-target CT/MRI lesions stable to smaller in size; or, Partial Response (PR)=at least 30% decrease in the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size. | Day 60 +/- 10 days post Therapeutic Dose |
| Quality of Life | Patients (aged 5-18) and parents (of patients aged 2-18) were asked to complete the 23-item Pediatric Quality of Life InventoryTM (PedsQLTM). PedsQLTM consists of 4 scales (physical, emotional, social, school functioning) which are then averaged into an overall summary score (scale: 0-100 with 0 representing the worst possible Quality of Life overall summary score and 100 representing the best possible Quality of Life overall summary score). The mean difference between the post treatment overall summary score and the baseline overall summary score is reported. | Day 60 +/- 10 days post Therapeutic Dose |
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| University of Chicago Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ultratrace™ Iobenguane I 131 | Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing began at 12.0 mCi/kg and escalated to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Maximum Tolerated Dose | The maximum tolerated dose (MTD) was defined as the dose immediately below the level at which dose escalation would be stopped due to dose limiting toxicities (DLTs). Once the MTD was reached, an additional 3 patients were to be treated at that dose level, for a total of 6 patients at that planned dose level. DLTs were defined as any of the events that are possibly, probably or definitely attributable to UltratraceTM iobenguane I 131. The MTD was supposed to be the highest dose tested at which fewer than 1/3 of pts experience a DLT when 6 patients have been treated at the MTD but the dosimetry results indicated that the maximal dosage allowed to normal organs would be exceeded if the highest planned dose (21.0 mCi/kg) was administered, so the highest dose administered in the study was 18.6 mCi/kg . | A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131. | Posted | Number | mCi/kg | Day 60 +/-10 or Engraftment, whichever comes first |
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| ||||||||||||||||||||||||||
| Secondary | Dose Limiting Toxicities | Dose limiting toxicities include treatment emergent adverse events (TEAEs) that were possibly, probably, or definitely related to Ultratrace™ Iobenguane I 131. | A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131. | Posted | Number | number of DLTs | From the time of signed informed consent until Day 60 or until the end of therapy evaluation is completed (whichever comes first). |
| ||||||||||||||||||||||||||||
| Secondary | Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions | The dosimetric endpoint was to estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following an imaging dose of 0.1 mCi/kg Ultratrace™ Iobenguane I 131. Biodistribution was assessed by determination of total body residence (TBR) time and by visual examination of whole body camera images. 3 timepoints were used, the 1st image was taken within 1hr after the imaging dose, the 2nd image was taken at ~24hr after imaging dose, the 3rd image was taken 2-5d after imaging dose. Whole body radiation absorbed dose estimates & kidney, liver, and lung were calculated using the Medical Internal Radiation Dose (MIRD) schema.TBR time is derived from time integration of curve-fitted injected activity across all 3 timepoints when the isotope is emitting radiation.Three points are sampled to estimate a singular value for each organ and tissue according to the commonly used methods of the Society of Nuclear Medicine and Molecular Imaging Committee on MIRD. | A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection). | Posted | Mean | Standard Deviation | Gy | Day 5 post Dosimetric Dose |
| |||||||||||||||||||||||||||
| Secondary | Overall Objective Tumor Response Post Therapeutic Treatment | The International Neuroblastoma Response Criteria (INRC) were utilized as a basis for the overall response criteria, which incorporated responses in MIBG positive lesions,bone marrow disease, and CT/MRI lesions that met NANT-modified RECIST criteria. Efficacy success was defined as the proportion of pts who were successful overall [i.e., achieving a Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)] determined by independent reviewers. CR = Disappearance of all target lesions, homovanillic acid/ vanillylmandelic acid (HVA/VMA) normal (NL); VGPR = > 90% decr of disease for CT/MRI target lesions, all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD/CR in soft tissue lesions. CR in bone marrow, no new tumor sites, and NL HVA/VMA.; PR = At least 30% decr in disease measurement for CT/MRI target lesions. Bone marrow with CR, MIBG with either PR/CR in bone lesions, MIBG may be SD /CR in soft tissue lesions, and HVA/VMA may still be elevated. | The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population. | Posted | Number | 95% Confidence Interval | proportion of evaluable population | Day 60 +/- 10 days post Therapeutic Dose |
| |||||||||||||||||||||||||||
| Secondary | Tumor Response in CT/MRI Lesions Post Therapeutic Treatment | Measurable disease was defined for a conventional CT scan by the presence of at least one lesion that could be accurately measured in at least one dimension with the longest diameter at least 20 mm by Independent Review. Efficacy success was defined as a patient achieving a Complete Response (CR)=disappearance of all target and non-target CT/MRI lesions; or, Very Good Partial Response (VGPR)=greater than 90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurement disease at study entry. Non-target CT/MRI lesions stable to smaller in size; or, Partial Response (PR)=at least 30% decrease in the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size. | The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population. | Posted | Number | 95% Confidence Interval | percentage of evaluable population | Day 60 +/- 10 days post Therapeutic Dose |
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| Secondary | Quality of Life | Patients (aged 5-18) and parents (of patients aged 2-18) were asked to complete the 23-item Pediatric Quality of Life InventoryTM (PedsQLTM). PedsQLTM consists of 4 scales (physical, emotional, social, school functioning) which are then averaged into an overall summary score (scale: 0-100 with 0 representing the worst possible Quality of Life overall summary score and 100 representing the best possible Quality of Life overall summary score). The mean difference between the post treatment overall summary score and the baseline overall summary score is reported. | Self reported PedsQL™ scores were obtained for 9 patients in the ITT population (n=15) at baseline (prior to the start of the Ultratrace™ Iobenguane I 131 imaging studies) and at the end of therapy (60 ±10 days post treatment). | Posted | Mean | Standard Deviation | units on a scale | Day 60 +/- 10 days post Therapeutic Dose |
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From the time of signed informed consent until Day or until the end of therapy evaluation was completed (whichever occurred first).
Serious adverse events (SAEs) that were ongoing at study completion (Day 60 ±10 days) were followed for 60 days or until resolution, whichever occurred first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultratrace™ Iobenguane I 131 | Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Mean therapeutic dosing groups were 11.2 mCi/kg, 15.5 nCi/kg and 18.2 mCi/kg. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes. | 5 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) |
| ||
| Infection | Infections and infestations | MedDRA (11.0) |
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| Bacteremia | Infections and infestations | MedDRA (11.0) |
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| Disease progression | General disorders | MedDRA (11.0) |
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| Neutropenia infection | Infections and infestations | MedDRA (11.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.0) |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (11.0) |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) |
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| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) |
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| Hemoglobin decreased | Investigations | MedDRA (11.0) |
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| Alanine aminotransferase increased | Investigations | MedDRA (11.0) |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA (11.0) |
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| Blood bilirubin increased | Investigations | MedDRA (11.0) |
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| Weight decreased | Investigations | MedDRA (11.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) |
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| Salivary gland pain | Gastrointestinal disorders | MedDRA (11.0) |
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| Salivary gland enlargement | Gastrointestinal disorders | MedDRA (11.0) |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) |
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| Constipation | Gastrointestinal disorders | MedDRA (11.0) |
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| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (11.0) |
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| Pyrexia | General disorders | MedDRA (11.0) |
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| Fatigue | General disorders | MedDRA (11.0) |
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| Oedema peripheral | General disorders | MedDRA (11.0) |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
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| Candidiasis | Infections and infestations | MedDRA (11.0) |
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| Headache | Nervous system disorders | MedDRA (11.0) |
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| Dysgeusia | Nervous system disorders | MedDRA (11.0) |
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| Bladder spasm | Renal and urinary disorders | MedDRA (11.0) |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
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| Hypertension | Vascular disorders | MedDRA (11.0) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| NANT Operations Center | NANT Consortium | 323-361-5687 | nantops@chla.usc.edu |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| 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 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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