NCT02576990 · OUTCOME
Number of Participants Who Discontinued Study Drug Due to an 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 27 months (Database Cutoff Date: 28MAY2019)
What was measured
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study drug due to an AE were reported.
Analysis population: The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Groups in this outcome
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
| Group | Source count |
|---|---|
| Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 53 |
| Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 6 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study drug due to an AE were reported.
- groups
- description
- Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
- id
- OG000
- title
- Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
- description
- Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
- id
- OG001
- title
- Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
- reporting Status
- POSTED
- time Frame
- Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
- title
- Number of Participants Who Discontinued Study Drug Due to an AE
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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