TriangleNCT03958656 · OUTCOME
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
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, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
What was measured
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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: 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,
Groups in this outcome
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
LEVEL 2 - 2.0x10^6 Per kg
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
LEVEL 3 - 6.0x10^6 Per kg
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
LEVEL 4 - 12.0x10^6 Per kg
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
| Group | Source count |
|---|---|
| LEVEL 1 - 0.66x10^6 Per Kilogram (kg) | 3 |
| LEVEL 2 - 2.0x10^6 Per kg | 3 |
| LEVEL 3 - 6.0x10^6 Per kg | 3 |
| LEVEL 4 - 12.0x10^6 Per kg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LEVEL 1 - 0.66x10^6 Per Kilogram (kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| LEVEL 2 - 2.0x10^6 Per kg | 3 | Not reported | Not reported | Not reported | Not reported |
| LEVEL 3 - 6.0x10^6 Per kg | 3 | Not reported | Not reported | Not reported | Not reported |
| LEVEL 4 - 12.0x10^6 Per kg | 1 | 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
- 3
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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
- 0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
- id
- OG000
- title
- LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
- description
- 2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
- id
- OG001
- title
- LEVEL 2 - 2.0x10^6 Per kg
- description
- 6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
- id
- OG002
- title
- LEVEL 3 - 6.0x10^6 Per kg
- description
- 12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
- id
- OG003
- title
- LEVEL 4 - 12.0x10^6 Per kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
- title
- Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice