Added disease assessments to the section ‘Transition Visit’; Removed central lab wording from ‘Clinical Laboratory Assessments’ because central labs were not used; Incorporated liver function tests into the clinical chemistries table to insure that liver function tests were to be administered whenever clinical chemistries were due; Updated the AE monitoring language to mention that the AEs will be monitored till the final study visit.; Updated to mention that the subject must be withdrawn from the study if there was a third dose reduction or reduction of dose below 75 mg; Added standard acetaminophen protein adduct testing to liver event follow-up assessments; Updated the list of prohibited and cautionary medications; Updated the section for non-drug therapies to mention that the administration of herbal medication (which was prohibited during study) was to be recorded in the eCRF; Added definition of disease state, response criteria and response definition for Langerhans cell histocytosis (LCH)

IR tablet description was added because the formulation was changed to tablet from capsule. The protocol description, synopsis, study treatments and dosage/administration sections were all updated to reflect this change; The introduction, summary of risk management, supportive measures for hyperglycemia, management of diarrhea, rash, dyspepsia, mucositis, liver chemistry stopping criteria, drug restart/rechallenge, con meds and non-drug therapies, meals and dietary restrictions and liver safety drug restart guidelines sections have all been updated with the latest information; Multiple myeloma specific disease assessments were added; AE follow-up was shortened to 30 days.

After the acquisition of GSK compound GSK2110183 (afuresertib), the purpose of this protocol Amendment 03 was to: Delete or replace references to GSK or its staff with that of Novartis and its authorized agents to align with the change of sponsorship; Make administrative changes to align with Novartis processes and procedures.