TriangleNCT03817853 · OUTCOME
Time to IRR From Infusion to Onset of the IRR During Cycle 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Hours
- Interval / dispersion
- Standard Deviation
- Time frame
- From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)
What was measured
Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2.
Analysis population: The SDI population included all enrolled participants who did not experience a Grade 3 or 4 IRR during cycle 1 (i.e. at any of the three Cycle 1 infusions), received obinutuzumab given at the standard rate only during Cycle 1, and received obinutuzumab as an SDI at cycle 2. For this outcome measure, only one participant was analyzed.
Groups in this outcome
All Participants
Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
| Group | Source count |
|---|---|
| All Participants | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 11.800 | NA | Not reported | Not reported | Standard deviation (SD) is not available because only 1 participant had the time to IRR recorded and the SD for one value is not defined. |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation (SD) is not available because only 1 participant had the time to IRR recorded and the SD for one value is not defined.
- group Id
- OG000
- spread
- NA
- value
- 11.800
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
- id
- OG000
- title
- All Participants
- param Type
- MEAN
- population Description
- The SDI population included all enrolled participants who did not experience a Grade 3 or 4 IRR during cycle 1 (i.e. at any of the three Cycle 1 infusions), received obinutuzumab given at the standard rate only during Cycle 1, and received obinutuzumab as an SDI at cycle 2. For this outcome measure, only one participant was analyzed.
- reporting Status
- POSTED
- time Frame
- From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)
- title
- Time to IRR From Infusion to Onset of the IRR During Cycle 2
- type
- SECONDARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice