TriangleNCT02689453 · OUTCOME
Number of Participants With Serious and/or Non-serious Adverse Events Regardless of Attribution 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 16 months and 14 days for level 1, 18 months and 12 days for level 2, and 14 months and 24 days for level 3.
What was measured
Here is the number of participants with serious and/or non-serious adverse events regardless of attribution assessed by the Common Terminology Criteria for Adverse Events (CTCAE 5.0). 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
Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)
IL-15 for 10 doses over two weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.
Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab
IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab
IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
| Group | Source count |
|---|---|
| Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15) | 3 |
| Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab | 4 |
| Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15) | 3 | Not reported | Not reported | Not reported | Not reported |
| Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Here is the number of participants with serious and/or non-serious adverse events regardless of attribution assessed by the Common Terminology Criteria for Adverse Events (CTCAE 5.0). 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
- IL-15 for 10 doses over two weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.
- id
- OG000
- title
- Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)
- description
- IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
- id
- OG001
- title
- Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab
- description
- IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
- id
- OG002
- title
- Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approximately 16 months and 14 days for level 1, 18 months and 12 days for level 2, and 14 months and 24 days for level 3.
- title
- Number of Participants With Serious and/or Non-serious Adverse Events Regardless of Attribution 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