TriangleNCT01647711 · OUTCOME
Percentage of Participants With Dose Limiting Toxicities
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- 28 days
What was measured
Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.
Analysis population: Treated set including patients eligible for MTD determination
Groups in this outcome
Afatinib 90mg
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 150mg
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 160mg
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 200mg
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
| Group | Source count |
|---|---|
| Afatinib 90mg | 6 |
| Afatinib 120mg | 3 |
| Afatinib 150mg | 7 |
| Afatinib 160mg | 9 |
| Afatinib 200mg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 90mg | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 120mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 150mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 160mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 200mg | 40.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16.7
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 40.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.
- groups
- description
- Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG000
- title
- Afatinib 90mg
- description
- Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG001
- title
- Afatinib 120mg
- description
- Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG002
- title
- Afatinib 150mg
- description
- Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG003
- title
- Afatinib 160mg
- description
- Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG004
- title
- Afatinib 200mg
- param Type
- NUMBER
- population Description
- Treated set including patients eligible for MTD determination
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Percentage of Participants With Dose Limiting Toxicities
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice