TriangleNCT04211337 · OUTCOME
Comparative Tolerability: Number of Weeks With High Side Effect Bother Based Score of 3 or 4 on the Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Weeks
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 Months
What was measured
Comparative tolerability defined as a comparison of the proportion of time on treatment with high side effect bother as assessed by the FACT-GP5. The FACT-GP5 is a single question used to assess the overall bother of the treatment side effects. It is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bother from treatment side effects. Time with high side effect bother (i.e.) score of 3 or 4 is reported here and was derived as follows: cumulative amount of time, in weeks, during which a participant reports high side effect bother divided by the total duration of therapy (weeks), derived as (date of last study treatment dose - date of first study treatment dose + 1) divided by 7.
Analysis population: All participants who received the first dose of study treatment prior to the interim efficacy analysis and at least 6 months prior to the data cutoff date. Analysis of tolerability will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated").
Groups in this outcome
Selpercatinib (TRT A)
160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
Cabozantinib or Vandetanib (TRT B)
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
| Group | Source count |
|---|---|
| Selpercatinib (TRT A) | 145 |
| Cabozantinib or Vandetanib (TRT B) | 77 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selpercatinib (TRT A) | 0.08 | 0.169 | Not reported | Not reported | Not reported |
| Cabozantinib or Vandetanib (TRT B) | 0.24 | 0.304 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.10
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).
- param Type
- Mean Difference (Final Values)
- param Value
- -0.16
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- ci Lower Limit
- -0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.10
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).
- param Type
- Mean Difference (Final Values)
- param Value
- -0.16
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.169
- value
- 0.08
- group Id
- OG001
- spread
- 0.304
- value
- 0.24
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 77
- units
- Participants
- description
- Comparative tolerability defined as a comparison of the proportion of time on treatment with high side effect bother as assessed by the FACT-GP5. The FACT-GP5 is a single question used to assess the overall bother of the treatment side effects. It is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bother from treatment side effects. Time with high side effect bother (i.e.) score of 3 or 4 is reported here and was derived as follows: cumulative amount of time, in weeks, during which a participant reports high side effect bother divided by the total duration of therapy (weeks), derived as (date of last study treatment dose - date of first study treatment dose + 1) divided by 7.
- dispersion Type
- Standard Deviation
- groups
- description
- 160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
- id
- OG000
- title
- Selpercatinib (TRT A)
- description
- 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
- id
- OG001
- title
- Cabozantinib or Vandetanib (TRT B)
- param Type
- MEAN
- population Description
- All participants who received the first dose of study treatment prior to the interim efficacy analysis and at least 6 months prior to the data cutoff date. Analysis of tolerability will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated").
- reporting Status
- POSTED
- time Frame
- Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 Months
- title
- Comparative Tolerability: Number of Weeks With High Side Effect Bother Based Score of 3 or 4 on the Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice