TriangleNCT02435433 · OUTCOME
Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Randomization to the First Date of Deterioration Observation (≥ 3-point decrease) (Up to 28 Months)
What was measured
The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease ≥ 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model.
Analysis population: All randomized participants who had evaluable FHSI-8 data.
Groups in this outcome
Ramucirumab + BSC
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
Placebo + BSC
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
| Group | Source count |
|---|---|
| Ramucirumab + BSC | 197 |
| Placebo + BSC | 95 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | 3.71 | Not reported | 2.79 | 4.40 | Not reported |
| Placebo + BSC | 2.79 | Not reported | 1.64 | 2.89 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.545
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.171
- estimate Comment
- Stratified analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2382
- param Type
- Hazard Ratio (HR)
- param Value
- 0.799
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.545
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.171
- estimate Comment
- Stratified analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2382
- param Type
- Hazard Ratio (HR)
- param Value
- 0.799
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.79
- upper Limit
- 4.40
- value
- 3.71
- group Id
- OG001
- lower Limit
- 1.64
- upper Limit
- 2.89
- value
- 2.79
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease ≥ 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
- id
- OG000
- title
- Ramucirumab + BSC
- description
- Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEDIAN
- population Description
- All randomized participants who had evaluable FHSI-8 data.
- reporting Status
- POSTED
- time Frame
- From Randomization to the First Date of Deterioration Observation (≥ 3-point decrease) (Up to 28 Months)
- title
- Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice