TriangleNCT02332980 · OUTCOME
Incidence of 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
- 1 year
What was measured
Will be measured per National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be evaluated for single-agent pembrolizumab in each arm and also for the combination of pembrolizumab and the signal inhibitor in Arm A and Arm C. This outcome is reported in the adverse events section of this report.
Groups in this outcome
Arm A (CLL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
Arm B (NHL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
| Group | Source count |
|---|---|
| Arm A (CLL) | 25 |
| Arm B (NHL) | 23 |
| Arm C (CLL With Richters) | 17 |
| Arm A (Continuation Phase) | 5 |
| Arm C (Continuation Phase) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (CLL) | 25 | Not reported | Not reported | Not reported | Not reported |
| Arm B (NHL) | 23 | Not reported | Not reported | Not reported | Not reported |
| Arm C (CLL With Richters) | 17 | Not reported | Not reported | Not reported | Not reported |
| Arm A (Continuation Phase) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Continuation Phase) | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 13
- units
- Participants
- description
- Will be measured per National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be evaluated for single-agent pembrolizumab in each arm and also for the combination of pembrolizumab and the signal inhibitor in Arm A and Arm C. This outcome is reported in the adverse events section of this report.
- groups
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
- id
- OG000
- title
- Arm A (CLL)
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG001
- title
- Arm B (NHL)
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
- id
- OG002
- title
- Arm C (CLL With Richters)
- description
- CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG003
- title
- Arm A (Continuation Phase)
- description
- CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG004
- title
- Arm C (Continuation Phase)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Incidence of Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice