TriangleNCT02215967 · OUTCOME
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
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
- Date treatment consent signed to date off study, approx. 3 mos and 7 days for DL 0.3 x 10^6 CAR + T cells, 4 mos and 4 days for 1.0 x 10^6 CAR + T cells, 9 mos and 13 days for 3.0 x 10^6 CAR + T cells, and 48 mos and 12 days for 9.0 x 10^6 CAR + T cells.
What was measured
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Analysis population: One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.
Groups in this outcome
0.3 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
1 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
3 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
9 x 10^6 CAR-BCMA T-cells Infused
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
| Group | Source count |
|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 3 |
| 1 x 10^6 CAR-BCMA T-cells Infused | 3 |
| 3 x 10^6 CAR-BCMA T-cells Infused | 4 |
| 9 x 10^6 CAR-BCMA T-cells Infused | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 3 | Not reported | Not reported | Not reported | Not reported |
| 1 x 10^6 CAR-BCMA T-cells Infused | 3 | Not reported | Not reported | Not reported | Not reported |
| 3 x 10^6 CAR-BCMA T-cells Infused | 4 | Not reported | Not reported | Not reported | Not reported |
| 9 x 10^6 CAR-BCMA T-cells Infused | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 16
- units
- Participants
- description
- Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- groups
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG000
- title
- 0.3 x 10^6 CAR-BCMA T-cells Infused
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG001
- title
- 1 x 10^6 CAR-BCMA T-cells Infused
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG002
- title
- 3 x 10^6 CAR-BCMA T-cells Infused
- description
- Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- id
- OG003
- title
- 9 x 10^6 CAR-BCMA T-cells Infused
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approx. 3 mos and 7 days for DL 0.3 x 10^6 CAR + T cells, 4 mos and 4 days for 1.0 x 10^6 CAR + T cells, 9 mos and 13 days for 3.0 x 10^6 CAR + T cells, and 48 mos and 12 days for 9.0 x 10^6 CAR + T cells.
- title
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice