TriangleNCT03598998 · OUTCOME
Number of Participants With Grade 3 4 5 Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From the start time of the initial treatment assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months).
What was measured
Number of Participants who had grade 3 4 5 toxicities at lease possibly related to study treatment. Toxicities were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade refers to the severity of the AE and ranges from 1 to 5 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death).
Groups in this outcome
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2 | 7 |
| Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Number of Participants who had grade 3 4 5 toxicities at lease possibly related to study treatment. Toxicities were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade refers to the severity of the AE and ranges from 1 to 5 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death).
- groups
- description
- Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
- description
- Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- From the start time of the initial treatment assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months).
- title
- Number of Participants With Grade 3 4 5 Adverse Events
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice