TriangleNCT02953652 · OUTCOME
Objective Response Rate
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
- Up to approximately 47 months.
What was measured
Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC). CR: Target nodes/nodal masses must regress to \<1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement. PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions.
Analysis population: The per-protocol analysis set (PPS) included subjects meeting all eligibility criteria who have completed Cycle 1 treatment. For subjects who developed clinical PD and discontinued study treatment during Cycle 1 without significant deviation from protocol, they will be included in the PPS. It should be noted that the PPS includes subjects who discontinued within Cycle 1 due to clinical PD without imaging studies to assess disease status.
Groups in this outcome
HBI-8000
HBI-8000 tablets
| Group | Source count |
|---|---|
| HBI-8000 | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HBI-8000 | 21 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21
- denoms
- counts
- group Id
- OG000
- value
- 46
- units
- Participants
- description
- Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC). CR: Target nodes/nodal masses must regress to \<1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement. PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions.
- groups
- description
- HBI-8000 tablets
- id
- OG000
- title
- HBI-8000
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The per-protocol analysis set (PPS) included subjects meeting all eligibility criteria who have completed Cycle 1 treatment. For subjects who developed clinical PD and discontinued study treatment during Cycle 1 without significant deviation from protocol, they will be included in the PPS. It should be noted that the PPS includes subjects who discontinued within Cycle 1 due to clinical PD without imaging studies to assess disease status.
- reporting Status
- POSTED
- time Frame
- Up to approximately 47 months.
- title
- Objective Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice