TriangleNCT02372006 · OUTCOME
Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort
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
- Assessed every 8 weeks until progression of disease, up to 336 days.
What was measured
Number of participants with objective response for maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.
Analysis population: Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
Groups in this outcome
Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
| Group | Source count |
|---|---|
| Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- Number of participants with objective response for maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.
- groups
- description
- Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
- id
- OG000
- title
- Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
- reporting Status
- POSTED
- time Frame
- Assessed every 8 weeks until progression of disease, up to 336 days.
- title
- Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice