TriangleNCT03905135 · 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 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2.
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.
Groups in this outcome
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
| Group | Source count |
|---|---|
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 6 |
| Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- 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
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- id
- OG000
- title
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- description
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- id
- OG001
- title
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2.
- 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