7. ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS Adverse event (AE) monitoring and reporting is a routine part of every clinical trial. The following list of AEs ( Section 7.1 ) and the characteristics of an observed AE ( Section 7.2 ) will determine whether the event requires expedited reporting (via CTEP-AERS) in addition to routine reporting. 7.1 Comprehensive Adverse Events and Potential Risks List(s) (CAEPRs) 7.1.1 CAEPRs for CTEP IND Agent(s): N/A 7.1.2 CAEPRs for INCB024360 (NSC 766086) The Comprehensive Adverse Event and Potentia l Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AE) associated with an agent using a uniform presentation of events by body system. In add ition to the comprehensive list, a subset, the Specific Protocol Exceptions to Expedited Reporti ng (SPEER), appears in a separate column and is identified with bold and italicized text. This subs et of AEs (SPEER) is a list of events that are protocol specific exceptions to expedited reporting to NCI vi a CTEP-AERS (except as noted below). Refer to the 'CTEP, NCI Guidel ines: Adverse Event Reporting Requirements' NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 40 http://ctep.cancer.gov/protocolDev elopment/electronic_applica tions/docs/aeguidelines.pdf for further clarification. The CAEPR does not provid e frequency data; refer to the Investigator's Brochure for this information. Below is the CAEPR for INCB024360. NOTE: Report AEs on the SPEER ONLY IF they exceed the grade noted in parentheses next to the AE in the SPEER. If this CAEPR is part of a combination protocol using multiple investigational agents and has an AE listed on different SPEERs, use the lower of the grades to determine if expedited reporting is required. Adverse Events with Possible Relationship to INCB024360 (CTCAE 4.0 Term) Version 1.1, October 15, 2015 Specific Protocol Exceptions to Expedited Reporting (SPEER) GASTROINTESTINAL DISORDERS Abdominal distension Abdominal Pain Abdominal pain (Gr 2) Constipation Constipation (Gr 2) Diarrhea Diarrhea (Gr 2) Nausea Nausea (Gr 2) Vomiting Vomiting (Gr 2) GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Edema limbs Edema limbs (Gr 2) Fatigue Fatigue (Gr 2) Fever Fever (Gr 1) Pain Pain (Gr 2) IMMUNE SYSTEM DISORDERS Autoimmune disorder2 INVESTIGATIONS Alanine aminotransferase increased Alanine aminotransferase increased (Gr 1) Aspartate aminotransferase increased Aspartate aminotransferase increased (Gr 1) Weight loss Weight loss (Gr 2) METABOLISM AND NUTRI TION DISORDERS NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 41 Anorexia Anorexia (Gr 2) Dehydration Dehydration (Gr 2) Hypokalemia Hypokalemia (Gr 2) MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia Back Pain Back pain (Gr 2) NERVOUS SYSTEM DISORDERS Dizziness Dysgeusia Headache Peripheral sensory neuropathy Peripheral sensory neuropathy (Gr 2) PSYCHIATRIC DISORDERS Insomnia RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Cough Cough (Gr 1) Dyspnea Dyspnea (Gr 1) Hypoxia SKIN AND SUBCUTANEOUS TISSUE DISORDERS Rash maculo-papular Rash maculo-papular (GR 2) 1This table will be updated as the toxicity profile of the agent is revised. Updates will be distributed to all Principal Inve stigators at the time of revisi on.