TriangleNCT01953692 · OUTCOME
Number of Participants Who Experienced One or More Adverse Events (AEs):
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
- Up to approximately 78.5 months
What was measured
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
Analysis population: All participants who received at least 1 dose of study treatment.
Groups in this outcome
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
| Group | Source count |
|---|---|
| Cohort 1: Myelodysplastic Syndrome (MDS) | 28 |
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 30 |
| Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) | 31 |
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 21 |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 4 |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 22 |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 42 |
| Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D) | 13 |
| Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Myelodysplastic Syndrome (MDS) | 27 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 28 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) | 31 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 21 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 21 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 38 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D) | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 38
- group Id
- OG007
- value
- 13
- group Id
- OG008
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 42
- group Id
- OG007
- value
- 13
- group Id
- OG008
- value
- 6
- units
- Participants
- description
- An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
- groups
- description
- Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 1: Myelodysplastic Syndrome (MDS)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG001
- title
- Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- description
- Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG002
- title
- Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG003
- title
- Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
- description
- Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG004
- title
- Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- Cohort 4C: R/R Follicular Lymphoma (FL)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
- id
- OG006
- title
- Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
- id
- OG007
- title
- Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
- id
- OG008
- title
- Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Number of Participants Who Experienced One or More Adverse Events (AEs):
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice