TriangleNCT03436732 · OUTCOME
Number of Participants With Serious and Non-Serious Adverse Events
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 one month and 25 days for the 100 mcg/kg Arm/Group, and 9 months and 28 days for the 140 mcg/kg Arm/Group.
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 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
140 mcg/kg
Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
100 mcg/kg
Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
| Group | Source count |
|---|---|
| 140 mcg/kg | 4 |
| 100 mcg/kg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 140 mcg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mcg/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
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- 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 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
- Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
- id
- OG000
- title
- 140 mcg/kg
- description
- Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
- id
- OG001
- title
- 100 mcg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approximately one month and 25 days for the 100 mcg/kg Arm/Group, and 9 months and 28 days for the 140 mcg/kg Arm/Group.
- title
- Number of Participants With Serious and Non-Serious Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice