TriangleNCT02858310 · OUTCOME
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for 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
- Adverse Events were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered up to a maximum of 12 months
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 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: 194/224 participants enrolled but not treated were not evaluable for this outcome.
Groups in this outcome
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
Participants Enrolled But Were Not Treated
Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
| Group | Source count |
|---|---|
| Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 3 |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 3 |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 6 |
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 18 |
| Participants Enrolled But Were Not Treated | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 18 | 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
- 6
- group Id
- OG003
- value
- 18
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 0
- 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 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
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- OG000
- title
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- OG001
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- id
- OG002
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- description
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- id
- OG003
- title
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- description
- Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
- id
- OG004
- title
- Participants Enrolled But Were Not Treated
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 194/224 participants enrolled but not treated were not evaluable for this outcome.
- reporting Status
- POSTED
- time Frame
- Adverse Events were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered up to a maximum of 12 months
- title
- Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice