TriangleNCT03000179 · OUTCOME
Overall Response Rate as Measured Using RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Measured every 8 weeks through study completion, an average of 1 year
What was measured
Response rate is the proportion of patients with overall complete (CR) or partial response(PR) among patients with valuable response outcome. Overall response will consider both target and non-target lesions, as well as new lesions. Target lesions by CT/MRI: CR: Disappearance of all target lesions. PR: \>= 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions, In addition, the sum must also demonstrate an absolute increase of at least 5 mm or appearance of new lesions. Non-target lesions: CR: Disappearance of all target lesions. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of applicable tumor marker level above the normal limits. PD: progression of existing non-target lesions.
Analysis population: Patients with advanced small intestinal adenocarcinoma or ampullary tumors, efficacy-evaluable.
Groups in this outcome
Avelumab Monotherapy
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks. Avelumab: Avelumab through a vein once every 2 weeks
| Group | Source count |
|---|---|
| Avelumab Monotherapy | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab Monotherapy | 0.29 | Not reported | 0.08 | 0.64 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.08
- upper Limit
- 0.64
- value
- 0.29
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- Response rate is the proportion of patients with overall complete (CR) or partial response(PR) among patients with valuable response outcome. Overall response will consider both target and non-target lesions, as well as new lesions. Target lesions by CT/MRI: CR: Disappearance of all target lesions. PR: \>= 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions, In addition, the sum must also demonstrate an absolute increase of at least 5 mm or appearance of new lesions. Non-target lesions: CR: Disappearance of all target lesions. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of applicable tumor marker level above the normal limits. PD: progression of existing non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks. Avelumab: Avelumab through a vein once every 2 weeks
- id
- OG000
- title
- Avelumab Monotherapy
- param Type
- NUMBER
- population Description
- Patients with advanced small intestinal adenocarcinoma or ampullary tumors, efficacy-evaluable.
- reporting Status
- POSTED
- time Frame
- Measured every 8 weeks through study completion, an average of 1 year
- title
- Overall Response Rate as Measured Using RECIST 1.1
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice