TriangleNCT00833833 · OUTCOME
Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1
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
- Up to Day 28 (Cycle 1)
What was measured
The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle. DLTs were defined as: * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment * Serum transaminase \> 20 \* upper limit of normal (ULN) * Serum transaminase \> 5 \* ULN for \>= 7 days * Delay of the start of cycle 2 by \>7 days due to pomalidomide-related adverse event
Analysis population: Safety population
Groups in this outcome
Phase 1: 2 mg Pomalidomide
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Phase 1: 3 mg Pomalidomide
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Phase 1: 4 mg Pomalidomide
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Phase 1: 5 mg Pomalidomide
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
| Group | Source count |
|---|---|
| Phase 1: 2 mg Pomalidomide | 6 |
| Phase 1: 3 mg Pomalidomide | 8 |
| Phase 1: 4 mg Pomalidomide | 14 |
| Phase 1: 5 mg Pomalidomide | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: 2 mg Pomalidomide | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 3 mg Pomalidomide | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 4 mg Pomalidomide | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: 5 mg Pomalidomide | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 10
- units
- Participants
- description
- The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle. DLTs were defined as: * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment * Serum transaminase \> 20 \* upper limit of normal (ULN) * Serum transaminase \> 5 \* ULN for \>= 7 days * Delay of the start of cycle 2 by \>7 days due to pomalidomide-related adverse event
- groups
- description
- Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG000
- title
- Phase 1: 2 mg Pomalidomide
- description
- Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG001
- title
- Phase 1: 3 mg Pomalidomide
- description
- Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG002
- title
- Phase 1: 4 mg Pomalidomide
- description
- Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
- id
- OG003
- title
- Phase 1: 5 mg Pomalidomide
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Up to Day 28 (Cycle 1)
- title
- Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice