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Treatment was continued until disease progression, onset of unacceptable toxicities, metastases surgery, or discontinuation request.
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Main reasons for discontinuation were request of the subjects (n = 11; 4 in the HC-ac 0.5% arm, 4 in the HC-ac 1% arm, and 3 in the HC-ac 2.5% arm) or AEs (n = 2; 1 in the HC-ac 1% arm, and 1 in the HC-ac 2.5% arm).
Subject responds to air stimulus but does not request discontinuation of stimulus.
Administration was discontinued if the patients or their legally authorised representatives requested discontinuation, or if the investigator deemed it necessary to discontinue administration due to serious adverse effects or progression of the disease.
Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Subject responds to air stimulus and requests discontinuation or moves from stimulus.
Reasons for switching to another OC or discontinuation will be requested if applicable.
Patients could be withdrawn from the study if their parents requested discontinuation of treatment because of lack of efficacy.
Similar to Study 305/EMBRACE, patients received study treatment until disease progression, unacceptable toxicity, or the patient or physician requested discontinuation of treatment.
One patient requested discontinuation of chemotherapy after 4 weeks of treatment, having previously required reductions in the irinotecan dose, but completed radiotherapy and subsequently underwent surgery.
Study treatment continued until: disease progression; unacceptable toxic effects; the patient or physician requested discontinuation; or serious non-compliance with the protocol.
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