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Early termination leading to no patients enrolled in cohort B.
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This trial is a pilot, Phase 2, sequential two-cohort study designed to test two de-escalated whole brain radiation therapy (WBRT) dose levels and assess their ability to maintain acceptable in-brain distant control. The WBRT dose would decrease as the study moves forward, both in terms of absolute value and equivalent dose in 2 Gray fractions (EQD2) (as determined by the linear quadratic radiobiological model). The absolute value of the simultaneous integrated boost (SIB) dose will change with each dose level because the number of fractions delivered will depend on the WBRT dose. As such, the SIB dose will be manipulated such that the EQD2 will remain essentially equivalent despite the difference in the number of fractions delivered. This design will ensure that the only variable is the change in WBRT dose.
The concept is that WBRT with SIB would be expected to maximize both local and in-brain distant control as has already been shown in studies exploring WBRT with SRS boost. However, by itself WBRT with SIB does not address the concern over neurocognitive outcomes. Therefore, investigators hypothesize that there is a lower WBRT dose threshold that will maintain acceptable in-brain distant control, particularly in the setting of a SIB to gross lesions to maintain treated lesion control. In addition, lower overall brain dose (including lower hippocampal dose without specific hippocampal avoidance) may potentially improve neurocognitive function. Investigators are also interested in evaluating treated lesion control, overall survival, neurocognitive sequelae of therapy, quality of life, performance status, and adverse effects of therapy. Biomarker identification for potential correlative circulating tumor DNA and microRNA is an exploratory endpoint to generate data for future prospective evaluation.
Primary Objective Evaluate two de-escalated whole brain radiation dose levels (in the setting of simultaneous integrated boost to gross lesions) with respect to in-brain distant control for brain metastases, defined as an in-brain failure rate outside of the planning target volume at 6 months of < 20%.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Standard PCI dose |
|
| Cohort B | Experimental | Low PCI dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort A | Radiation | Cohort A - WBRT dose = 25 Gy, SIB dose = 42 Gy, # of daily fractions = 10, SIB dose in EQD2 = 49.7 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-Brain Distant Failure Rate | An actuarial 6-month rate of new parenchymal lesions seen outside the planning target volume of any lesion that received SIB on any post-treatment MRI (in all 3 planes). This is the binomial proportion of patients who experienced in-brain distant failure by 6 months and the associated 95% confidence interval. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Treated Lesion Local Control | An actuarial 6-month rate of any new, recurrent, or progressing (as defined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria) tumor within the planning target volume on any post-treatment MRI. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last know alive or at the date of death if they expired. |
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Inclusion Criteria
Age ≥ 18 at time of consent.
Ability to provide written informed consent and HIPAA authorization.
Pathological diagnosis of any solid tumor histology (from any site in the body).
Pathological or clinical (i.e., by imaging) diagnosis of brain metastatic tumor lesions.
Total volume of lesions ≤ 30 cm3.
Maximum volume of largest lesion ≤ 5 cm3.
a. This volume limit would be equivalent to a largest diameter of about 2.1 cm, assuming a perfect sphere.
Not a candidate for or eligible for but refused Gamma Knife radiosurgery.
Exclusion Criteria
Of note, tumor lesion number is not an inclusion or exclusion criteria as we are using volume-based criteria instead.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin R. Shiue, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Melvin and Bren Simon Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Standard prophylactic intracranial irradiation (PCI) dose Cohort A: whole-brain radiation therapy dose (WBRT) = 25 Gy, simultaneous integrated boost (SIB) dose = 42 Gy, # of daily fractions = 10, SIB dose in equivalent dose in 2 Gray fractions (EQD2) = 49.7 Gy |
| FG001 | Cohort B | Low prophylactic intracranial irradiation (PCI) dose Cohort B: Cohort B - whole-brain radiation therapy dose (WBRT) dose = 20 Gy, simultaneous integrated boost (SIB) dose = 40 Gy, # of daily fractions = 8, SIB dose in equivalent dose in 2 Gray fractions (EQD2) = 50.0 Gy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are given for patients who had a treatment start date and were deemed eligible.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Standard PCI dose Cohort A: Cohort A - WBRT dose = 25 Gy, SIB dose = 42 Gy, # of daily fractions = 10, SIB dose in EQD2 = 49.7 Gy |
| BG001 | Cohort B | Low PCI dose Cohort B: Cohort B - WBRT dose = 20 Gy, SIB dose = 40 Gy, # of daily fractions = 8, SIB dose in EQD2 = 50.0 Gy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | In-Brain Distant Failure Rate | An actuarial 6-month rate of new parenchymal lesions seen outside the planning target volume of any lesion that received SIB on any post-treatment MRI (in all 3 planes). This is the binomial proportion of patients who experienced in-brain distant failure by 6 months and the associated 95% confidence interval. | Includes the patients evaluable for in-brain distant failure at 6 months. There were no patients accrued in cohort B. | Posted | Number | 95% Confidence Interval | proportion of patients | 6 Months |
|
Adverse events were collected throughout the study and assessed up to 39 months
There were no patients accrued in cohort B. Therefore, the number at risk for all events is zero.
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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 | Cohort A | Standard PCI dose Cohort A: Cohort A - WBRT dose = 25 Gy, SIB dose = 42 Gy, # of daily fractions = 10, SIB dose in EQD2 = 49.7 Gy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
Early termination leading to no patients enrolled in cohort B.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Shiue | Indiana University (IU) | 317 944 2524 | kshiue@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 | Mar 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Cohort B | Radiation | Cohort B - WBRT dose = 20 Gy, SIB dose = 40 Gy, # of daily fractions = 8, SIB dose in EQD2 = 50.0 Gy |
|
| 6 Months |
| Overall Survival for Evaluable Patients | An actuarial 6-month rate of patients still alive regardless of disease status. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. For patients who expired, the time from treatment start to death was calculated. Patients who did not expire were censored at the date last know alive. | 6 Months |
| Change in Neurocognitive Function From Baseline to 6 Months | The change in scores from the neurocognitive test were calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase from baseline and negative values indicate a decrease. The neurological test scores were assessed with the Hopkins Verbal Learning Test - Revised (HVLT). In the HVLT, 12 nouns are read and the participant is asked to recall in 3 rounds. Total words recalled are summed for the Total Recall score ranging from 0-36 (higher score represents better recall). The delayed recall score is tested 20-25 mins after the initial recall and ranges from 0-12 (higher scores are better). Retention (%) is the percentage of words recalled and ranges from 0-100 (higher values represent better recall). The recognition discrimination score is tested by a series of yes/no responses from the participant identifying 12 words from a list of 24 and subtracts the number of true positives minus the true negatives (higher values are better). | 6 Months |
| Change in Health-Related Quality of Life (QoL) From Baseline to 6 Months | The change in scores of health-related quality of life test from baseline to 6 months calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase in score from baseline to 6 months while negative values indicate a decrease. The Functional Assessment of Cancer Therapy with Brain Subscale (FACT-Br) asks questions on a scale from 0 to 4 with 0 being "not at all" and 4 being "very much". Responses were reversed, if applicable, and compiled to calculate physical well-being (range: 0-28), social/family well-being (range: 0-28), emotional well-being (range: 0-24), functional well-being (range: 0-28), bone marrow transplant (BMT) (range: 0-40), and brain cancer (range: 0-92) subscale scores. These subscale scores were then summed to obtain the trail outcome index (range: 0-148), bone marrow transplant (FACT-BMT) (range: 0-96), general (FACT-G) (range: 0-108), and FACT-Br (range: 0-200) total scores. The higher the score, the better the QoL. | 6 Months |
| Change in Performance Status | Total change in performance status score was calculated by substracting the baseline score from the follow-up score. Positive values indicate an increase in score from baseline while negative values indicate a decrease in score from baseline. Functional status evaluated using the Karnofsky Performance Score (KPS) Index. The KPS score is evaluated on a scale from 0 to 100 where 0 is death and 100 is "normal no complaints; no evidence of disease". | 12 Months |
| Incidence of Early and Late Treatment-Related Adverse Effects | This is the percentage of eligible patients who experienced the respective treatment-related AE while on study. Adverse effects (AEs) were defined per CTCAE and considered treatment-related if the AE start date occurred on or after the first date of treatment and it was possibly, probably, or definitely related to treatment. AEs were recorded from the start of treatment until the patient was off-study. | Up To 39 Months |
| Overall Survival for Eligible Patients | An actuarial 6-month rate of patients still alive regardless of disease status. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. For patients who expired, the time from treatment start to death was calculated. Patients who did not expire were censored at the date last know alive. | 6 Months |
| Change in Neurocognitive Function Retention Percentage Raw Score From Baseline to 6 Months | The change in scores from the neurocognitive test were calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase from baseline and negative values indicate a decrease. The neurological test scores were assessed with the Hopkins Verbal Learning Test - Revised (HVLT). In the HVLT, 12 nouns are read and the participant is asked to recall in 3 rounds. Total words recalled are summed for the Total Recall score ranging from 0-36 (higher score represents better recall). The delayed recall score is tested 20-25 mins after the initial recall and ranges from 0-12 (higher scores are better). Retention (%) is the percentage of words recalled and ranges from 0-100 (higher values represent better recall). The recognition discrimination score is tested by a series of yes/no responses from the participant identifying 12 words from a list of 24 and subtracts the number of true positives minus the true negatives (higher values are better). | 6 Months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
|
| Primary Cancer Diagnosis | Count of Participants | Participants |
|
| Number of Lesions at Baseline | Median | Inter-Quartile Range | lesions |
|
| Number of Boosted Lesions at Baseline | Median | Inter-Quartile Range | lesions |
|
Low PCI dose Cohort B: Cohort B - WBRT dose = 20 Gy, SIB dose = 40 Gy, # of daily fractions = 8, SIB dose in EQD2 = 50.0 Gy |
|
|
| Secondary | Treated Lesion Local Control | An actuarial 6-month rate of any new, recurrent, or progressing (as defined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria) tumor within the planning target volume on any post-treatment MRI. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last know alive or at the date of death if they expired. | Includes patients evaluable for 6-month outcomes. There were no patients accrued in cohort B. | Posted | Number | 95% Confidence Interval | survival probability | 6 Months |
|
|
|
| Secondary | Overall Survival for Evaluable Patients | An actuarial 6-month rate of patients still alive regardless of disease status. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. For patients who expired, the time from treatment start to death was calculated. Patients who did not expire were censored at the date last know alive. | Includes patients evaluable for 6-month outcomes. There were no patients accrued in cohort B. | Posted | Number | 95% Confidence Interval | survival probability | 6 Months |
|
|
|
| Secondary | Change in Neurocognitive Function From Baseline to 6 Months | The change in scores from the neurocognitive test were calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase from baseline and negative values indicate a decrease. The neurological test scores were assessed with the Hopkins Verbal Learning Test - Revised (HVLT). In the HVLT, 12 nouns are read and the participant is asked to recall in 3 rounds. Total words recalled are summed for the Total Recall score ranging from 0-36 (higher score represents better recall). The delayed recall score is tested 20-25 mins after the initial recall and ranges from 0-12 (higher scores are better). Retention (%) is the percentage of words recalled and ranges from 0-100 (higher values represent better recall). The recognition discrimination score is tested by a series of yes/no responses from the participant identifying 12 words from a list of 24 and subtracts the number of true positives minus the true negatives (higher values are better). | Includes patients evaluable for 6-month outcomes. There were no patients accrued in cohort B. | Posted | Median | Inter-Quartile Range | difference in score on a scale | 6 Months |
|
|
|
| Secondary | Change in Health-Related Quality of Life (QoL) From Baseline to 6 Months | The change in scores of health-related quality of life test from baseline to 6 months calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase in score from baseline to 6 months while negative values indicate a decrease. The Functional Assessment of Cancer Therapy with Brain Subscale (FACT-Br) asks questions on a scale from 0 to 4 with 0 being "not at all" and 4 being "very much". Responses were reversed, if applicable, and compiled to calculate physical well-being (range: 0-28), social/family well-being (range: 0-28), emotional well-being (range: 0-24), functional well-being (range: 0-28), bone marrow transplant (BMT) (range: 0-40), and brain cancer (range: 0-92) subscale scores. These subscale scores were then summed to obtain the trail outcome index (range: 0-148), bone marrow transplant (FACT-BMT) (range: 0-96), general (FACT-G) (range: 0-108), and FACT-Br (range: 0-200) total scores. The higher the score, the better the QoL. | Includes patients evaluable for 6-month outcomes. There were no patients accrued in cohort B. | Posted | Median | Inter-Quartile Range | scores on a scale | 6 Months |
|
|
|
| Secondary | Change in Performance Status | Total change in performance status score was calculated by substracting the baseline score from the follow-up score. Positive values indicate an increase in score from baseline while negative values indicate a decrease in score from baseline. Functional status evaluated using the Karnofsky Performance Score (KPS) Index. The KPS score is evaluated on a scale from 0 to 100 where 0 is death and 100 is "normal no complaints; no evidence of disease". | Includes patients evaluable for 6-month outcomes. There were no patients accrued in cohort B. | Posted | Median | Inter-Quartile Range | difference in score on a scale | 12 Months |
|
|
|
| Secondary | Incidence of Early and Late Treatment-Related Adverse Effects | This is the percentage of eligible patients who experienced the respective treatment-related AE while on study. Adverse effects (AEs) were defined per CTCAE and considered treatment-related if the AE start date occurred on or after the first date of treatment and it was possibly, probably, or definitely related to treatment. AEs were recorded from the start of treatment until the patient was off-study. | Includes the patients marked as eligible who started treatment. There were no patients accrued in cohort B. | Posted | Number | percentage of patients | Up To 39 Months |
|
|
|
| Secondary | Overall Survival for Eligible Patients | An actuarial 6-month rate of patients still alive regardless of disease status. This details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. For patients who expired, the time from treatment start to death was calculated. Patients who did not expire were censored at the date last know alive. | Includes patients who started treatment and were deemed eligible for the study. There were no patients accrued in cohort B. | Posted | Number | 95% Confidence Interval | survival probability | 6 Months |
|
|
|
| Secondary | Change in Neurocognitive Function Retention Percentage Raw Score From Baseline to 6 Months | The change in scores from the neurocognitive test were calculated by subtracting the baseline score from the 6-month score. Positive values indicate an increase from baseline and negative values indicate a decrease. The neurological test scores were assessed with the Hopkins Verbal Learning Test - Revised (HVLT). In the HVLT, 12 nouns are read and the participant is asked to recall in 3 rounds. Total words recalled are summed for the Total Recall score ranging from 0-36 (higher score represents better recall). The delayed recall score is tested 20-25 mins after the initial recall and ranges from 0-12 (higher scores are better). Retention (%) is the percentage of words recalled and ranges from 0-100 (higher values represent better recall). The recognition discrimination score is tested by a series of yes/no responses from the participant identifying 12 words from a list of 24 and subtracts the number of true positives minus the true negatives (higher values are better). | Includes patients evaluable for 6-month outcomes. There were no patients accrued in cohort B. | Posted | Median | Inter-Quartile Range | percentage | 6 Months |
|
|
|
| 15 |
| 20 |
| 9 |
| 20 |
| 20 |
| 20 |
| EG001 | Cohort B | Low PCI dose Cohort B: Cohort B - WBRT dose = 20 Gy, SIB dose = 40 Gy, # of daily fractions = 8, SIB dose in EQD2 = 50.0 Gy | 0 | 0 | 0 | 0 | 0 | 0 |
| Breast infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Papulopustular rash | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Breast infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Cardiac troponin I increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
|
|
| Functional Well-Being |
|
| Bone Marrow Transplant (BMT) Subscale |
|
| Trial Outcome Index |
|
| FACT-G |
|
| FACT-BMT |
|
|
| Title | Measurements |
|---|---|
|
| Headache |
|
| Somnolence |
|
| Blurred Vision |
|
| Cognitive Disturbance |
|
| Dermatitis Radiation |
|
| Dry Skin |
|
| Mucosal Infection |
|
| Oral Pain |
|
| Papulopustular Rash |
|
| Pruritus |
|
| Rash Maculo-Papular |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Vomiting |
|