TriangleNCT03375320 · OUTCOME
Number of Patients Experiencing Grade 3+ Adverse Events (AEs) Graded According to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 60 months
What was measured
For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.
Groups in this outcome
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
| Group | Source count |
|---|---|
| Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 134 |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 69 |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 64 |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 104 | Not reported | Not reported | Not reported | Not reported |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 47 | Not reported | Not reported | Not reported | Not reported |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 49 | Not reported | Not reported | Not reported | Not reported |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 22 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 49
- group Id
- OG003
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 69
- group Id
- OG002
- value
- 64
- group Id
- OG003
- value
- 31
- units
- Participants
- description
- For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.
- groups
- description
- Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG000
- title
- Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
- description
- Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG001
- title
- Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
- description
- Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG002
- title
- Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
- description
- Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG003
- title
- Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 60 months
- title
- Number of Patients Experiencing Grade 3+ Adverse Events (AEs) Graded According to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice