TriangleNCT03817853 · OUTCOME
Percentage of Participants With Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to end of study (approximately 4 years)
What was measured
An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Analysis population: The safety population included all participants who received at least one dose of obinutuzumab.
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.
Maintenance: Obinutuzumab
Participants 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. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).
Follow-up
Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
| Group | Source count |
|---|---|
| All Participants | 113 |
| Maintenance: Obinutuzumab | 95 |
| Follow-up | 99 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 99.1 | Not reported | Not reported | Not reported | Not reported |
| Maintenance: Obinutuzumab | 90.5 | Not reported | Not reported | Not reported | Not reported |
| Follow-up | 27.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99.1
- group Id
- OG001
- value
- 90.5
- group Id
- OG002
- value
- 27.3
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 95
- group Id
- OG002
- value
- 99
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
- 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
- description
- Participants 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. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).
- id
- OG001
- title
- Maintenance: Obinutuzumab
- description
- Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
- id
- OG002
- title
- Follow-up
- param Type
- NUMBER
- population Description
- The safety population included all participants who received at least one dose of obinutuzumab.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of study (approximately 4 years)
- title
- Percentage of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice