{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.00","upperLimit":"6.00","value":"3.00"},{"groupId":"OG001","lowerLimit":"2.00","upperLimit":"5.05","value":"2.75"},{"groupId":"OG002","lowerLimit":"2.00","upperLimit":"8.00","value":"4.17"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"25"}],"units":"Participants"}],"description":"Time from (last) dosing to the maximum measured concentration at steady state (tmax,ss) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported.","dispersionType":"Full Range","groups":[{"description":"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \\[BSA\\] using allometric scaling):\n\nOral 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.\n\nTherapy 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.\n\nAfatinib 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":"Dose Finding - Level 0"},{"description":"Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \\[BSA\\] using allometric scaling):\n\nOral 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.\n\nTherapy 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.\n\nAfatinib 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":"OG001","title":"Dose Finding - Level 1"},{"description":"Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \\[BSA\\] using allometric scaling):\n\nOral 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.\n\nTherapy 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.\n\nAfatinib 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":"OG002","title":"Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0"}],"paramType":"MEDIAN","populationDescription":"Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.","title":"Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort","type":"SECONDARY","unitOfMeasure":"Hours"}