NCT03994705 · OUTCOME
Number of Participants With Treatment-Related Adverse Events
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
- Time Frame: 21 days
What was measured
Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma
Analysis population: Participants with treatment related adverse event
Groups in this outcome
Dose-Escalation Level 1
Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 10 million cells of Descartes-11 via intravenous catheter
Dose Level 2
Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 32 million cells of Descartes-11 via intravenous catheter
Dose Level 3
Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter
Dose Level 4A
Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter
Dose Level 4B
Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter
Dose Level 4C
Participants were not administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter
| Group | Source count |
|---|---|
| Dose-Escalation Level 1 | 3 |
| Dose Level 2 | 4 |
| Dose Level 3 | 3 |
| Dose Level 4A | 2 |
| Dose Level 4B | 4 |
| Dose Level 4C | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-Escalation Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4A | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4B | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4C | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma
- groups
- description
- Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 10 million cells of Descartes-11 via intravenous catheter
- id
- OG000
- title
- Dose-Escalation Level 1
- description
- Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 32 million cells of Descartes-11 via intravenous catheter
- id
- OG001
- title
- Dose Level 2
- description
- Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter
- id
- OG002
- title
- Dose Level 3
- description
- Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter
- id
- OG003
- title
- Dose Level 4A
- description
- Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter
- id
- OG004
- title
- Dose Level 4B
- description
- Participants were not administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter
- id
- OG005
- title
- Dose Level 4C
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants with treatment related adverse event
- reporting Status
- POSTED
- time Frame
- Time Frame: 21 days
- title
- Number of Participants With Treatment-Related Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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