TriangleNCT01953692 · OUTCOME
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
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) | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- 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 Discontinued Study Treatment Due to an Adverse Event (AE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice