NCT03849651 · OUTCOME
The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity
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
- 28 days after receiving first dose of Blinatumomab (up to approximately 7 months post-transplant)
What was measured
If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued
Analysis population: Patients who met eligibility criteria, received transplant, and received blinatumomab.
Groups in this outcome
All Transplant Participants
Patients who met eligibility criteria and received transplant during the dose-finding phase.
Dose 1
Patients who met eligibility criteria, received transplant, received 1x10\^5 cells/kg, and received blinatumomab
Dose 2
Patients who met eligibility criteria, received transplant, received 1x10\^6 cells/kg, and received blinatumomab
Dose 3
Patients who met eligibility criteria, received transplant, received 1x10\^7 cells/kg, and received blinatumomab
Phase 2
Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
| Group | Source count |
|---|---|
| All Transplant Participants | 26 |
| Dose 1 | 5 |
| Dose 2 | 3 |
| Dose 3 | 8 |
| Phase 2 | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Transplant Participants | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 10
- units
- Participants
- description
- If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued
- groups
- description
- Patients who met eligibility criteria and received transplant during the dose-finding phase.
- id
- OG000
- title
- All Transplant Participants
- description
- Patients who met eligibility criteria, received transplant, received 1x10\^5 cells/kg, and received blinatumomab
- id
- OG001
- title
- Dose 1
- description
- Patients who met eligibility criteria, received transplant, received 1x10\^6 cells/kg, and received blinatumomab
- id
- OG002
- title
- Dose 2
- description
- Patients who met eligibility criteria, received transplant, received 1x10\^7 cells/kg, and received blinatumomab
- id
- OG003
- title
- Dose 3
- description
- Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
- id
- OG004
- title
- Phase 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patients who met eligibility criteria, received transplant, and received blinatumomab.
- reporting Status
- POSTED
- time Frame
- 28 days after receiving first dose of Blinatumomab (up to approximately 7 months post-transplant)
- title
- The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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