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The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.
All eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and 75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of two antiemetic treatment sequences: sequence A that involves administration of ondansetron alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for 3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one primary endpoint: complete response (CR) rate. Participation in this study may result in reduced chemo-radiation induced nausea and vomiting, however, risks include the common side effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia, urinary tract infection, stomatitis, and anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Active Comparator | Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks. |
|
| Sequence B | Active Comparator | Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rolapitant | Drug | single 180 mg dose by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT) | The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Weeks 1 and 2 |
| Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes | The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing. | Weeks 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone | The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with "Which nausea medication regimen was I most satisfied with?" | Weeks 1-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Lou Affronti, DNP, RN, ANP, MHSc | The Preston Robert Tisch Brain Tumor Center at Duke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Preston Robert Tisch Brain Tumor Center at Duke | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| The Preston Robert Tisch Brain Tumor Center at Duke | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks. Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily |
| FG001 | Sequence B | Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks. Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A | Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks. Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily |
| BG001 | Sequence B |
| 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 | Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT) | The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Four participants in each group did not complete MATs for the first two weeks. | Posted | Number | proportion of participants | Weeks 1 and 2 |
|
8 weeks
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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 | Period 1 Rolapitant + Ondansetron | Weeks 1-3 Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Herndon II, Ph.D. | Duke University | 919-668-8145 | james.herndon@duke.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 | Feb 18, 2022 | May 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D005910 | Glioma |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018302 | Neoplasms, Neuroepithelial |
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| ID | Term |
|---|---|
| C578834 | rolapitant |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ondansetron | Drug | 8 mg by mouth daily |
|
|
| Week 3 Patient Satisfaction: Effectiveness |
Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness. |
| Weeks 1-3 |
| Week 3 Patient Satisfaction: Convenience | Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience. | Weeks 1-3 |
| Week 3 Patient Satisfaction: Overall Satisfaction | Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction. | Weeks 1-3 |
| Week 6 Patient Satisfaction: Effectiveness | Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness. | Weeks 4-6 |
| Week 6 Patient Satisfaction: Convenience | Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience. | Weeks 4-6 |
| Week 6 Patient Satisfaction: Overall Satisfaction | Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction. | Weeks 4-6 |
| Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks | The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Weeks 1 and 2 |
| Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes | The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing. | Weeks 1 and 2 |
| Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks | The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Weeks 1 and 2 |
| Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes | The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing. | Weeks 1 and 2 |
| Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks | The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Weeks 1-6 |
| Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks | The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Weeks 1-6 |
| Ondansetron Medication Compliance Weeks 1-3 | Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3. | Weeks 1-3 |
| Ondansetron Medication Compliance Weeks 4-6 | Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6. | Weeks 4-6 |
| Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events | The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events. | 8 weeks |
| Withdrawal by Subject |
|
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks. Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily |
| 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 | Count of Participants | Participants |
|
| OG001 |
| Sequence B |
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks. Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily |
|
|
|
| Primary | Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes | The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing. | Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants. | Posted | Number | proportion of participants | Weeks 1 and 2 |
|
|
|
|
| Secondary | Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone | The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with "Which nausea medication regimen was I most satisfied with?" | Participants who provided treatment preference data. | Posted | Count of Participants | Participants | Weeks 1-6 |
|
|
|
|
| Secondary | Week 3 Patient Satisfaction: Effectiveness | Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness. | Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 3. | Posted | Mean | Standard Deviation | score on a scale | Weeks 1-3 |
|
|
|
|
| Secondary | Week 3 Patient Satisfaction: Convenience | Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience. | Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 3. | Posted | Mean | Standard Deviation | score on a scale | Weeks 1-3 |
|
|
|
|
| Secondary | Week 3 Patient Satisfaction: Overall Satisfaction | Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction. | Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 3. | Posted | Mean | Standard Deviation | score on a scale | Weeks 1-3 |
|
|
|
|
| Secondary | Week 6 Patient Satisfaction: Effectiveness | Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness. | Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 6. | Posted | Mean | Standard Deviation | score on a scale | Weeks 4-6 |
|
|
|
|
| Secondary | Week 6 Patient Satisfaction: Convenience | Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience. | Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 6. | Posted | Mean | Standard Deviation | score on a scale | Weeks 4-6 |
|
|
|
|
| Secondary | Week 6 Patient Satisfaction: Overall Satisfaction | Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction. | Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 6. | Posted | Mean | Standard Deviation | score on a scale | Weeks 4-6 |
|
|
|
|
| Secondary | Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks | The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Participants who completed MATs for the first two weeks. | Posted | Number | proportion of participants | Weeks 1 and 2 |
|
|
|
| Secondary | Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes | The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing. | Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants. | Posted | Number | proportion of participants | Weeks 1 and 2 |
|
|
|
| Secondary | Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks | The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Participants who completed MATs for the first two weeks. | Posted | Number | proportion of participants | Weeks 1 and 2 |
|
|
|
| Secondary | Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes | The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing. | Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants. | Posted | Number | proportion of participants | Weeks 1 and 2 |
|
|
|
| Secondary | Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks | The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Participants who completed MATs for six weeks and complied with treatment. | Posted | Number | proportion of participants | Weeks 1-6 |
|
|
|
| Secondary | Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks | The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). | Data not collected on 10 participants. | Posted | Number | proportion of participants | Weeks 1-6 |
|
|
|
| Secondary | Ondansetron Medication Compliance Weeks 1-3 | Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3. | Participants who remained on study and returned medication logs. | Posted | Number | percentage of participants | Weeks 1-3 |
|
|
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| Secondary | Ondansetron Medication Compliance Weeks 4-6 | Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6. | Participants who remained on study without schedule changes and returned medication logs. | Posted | Number | percentage of participants | Weeks 4-6 |
|
|
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| Secondary | Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events | The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events. | Posted | Number | proportion of participants | 8 weeks |
|
|
|
| 0 |
| 23 |
| 3 |
| 23 |
| 22 |
| 23 |
| EG001 | Period 1 Ondansetron | Weeks 1-3 Ondansetron: 8 mg by mouth daily | 0 | 25 | 0 | 25 | 23 | 25 |
| EG002 | Period 2 Rolapitant + Ondansetron | Weeks 4-6 Rolapitant: single 180 mg dose by mouth Ondansetron: 8 mg by mouth daily | 0 | 22 | 1 | 22 | 18 | 22 |
| EG003 | Period 2 Ondansetron | Weeks 4-6 Ondansetron: 8 mg by mouth daily | 0 | 23 | 2 | 23 | 21 | 23 |
| Psychosis | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blurred Vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bullous Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: "muffling" in right ear | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: ear fullness/muffling, hard to hear in both ears | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema Face | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema Limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: impaired vision, right eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: right eye inflammation | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye Pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Unspecified | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: constant feeling of being cold | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: oral fungal infection on tongue | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Injection Site Reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: blurred vision preventing reading, d/t radiation mask placement | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: swollen eyelids impeding eye opening, d/t radiation mask placement | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucosal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: temporomandibular joint inflammation causing nausea while chewing | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Otitis Externa | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pyramidal Tract Syndrome | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other, Specify: "bruising left hand from fall" | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| 0.5207 |
| Equivalence |
Three outcomes tested by sequence. |