TriangleNCT01445080 · OUTCOME
Number of Patients With Treatment-related Dose Limiting Toxicities in Later Cycles by Dose Level
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 2 years
What was measured
Number of patients with treatment-related dose limiting toxicities in later cycles, as defined by study protocol, stratified by dose level.
Analysis population: There were 55 evaluable patients
Groups in this outcome
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
PK Cohort Expanded: BAY 43-9006 200 mg/m^2
Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
| Group | Source count |
|---|---|
| Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2 | 6 |
| Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2 | 3 |
| Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2 | 12 |
| Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2 | 7 |
| Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2 | 2 |
| Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2 | 6 |
| Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2 | 2 |
| Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2 | 5 |
| PK Cohort Expanded: BAY 43-9006 200 mg/m^2 | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| PK Cohort Expanded: BAY 43-9006 200 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 12
- units
- Participants
- description
- Number of patients with treatment-related dose limiting toxicities in later cycles, as defined by study protocol, stratified by dose level.
- groups
- description
- Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
- id
- OG000
- title
- Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
- description
- Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
- id
- OG001
- title
- Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
- description
- Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
- id
- OG002
- title
- Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
- description
- Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
- id
- OG003
- title
- Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
- description
- Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
- id
- OG004
- title
- Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
- description
- Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
- id
- OG005
- title
- Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
- description
- Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
- id
- OG006
- title
- Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
- description
- Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
- id
- OG007
- title
- Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
- description
- Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
- id
- OG008
- title
- PK Cohort Expanded: BAY 43-9006 200 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- There were 55 evaluable patients
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Number of Patients With Treatment-related Dose Limiting Toxicities in Later Cycles by Dose Level
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice