Classification of Adverse Events. All AEs will be evaluated according to the NCI CTCAE v5.0 (effective 27 November 2017). If the AE is not listed in the CTCAE v5.0, it should be graded based on the description given in Table 10. Table 10: Adverse Event Severity Severity Definition Grade 1 (Mild) No limitation of usual activities. Grade 2 (Moderate) Some limitation of usual activities. Grade 3 (Severe) Inability to carry out usual activities. Grade 4 (Life-threatening) Immediate risk of death. Grade 5 (Fatal) Resulting in death. Relationship of an AE or SAE to study medication is to be determined by the Investigator based on the definitions in Table 11. Table 11: Adverse Event Causal Relatedness Relationship to Product(s) Definition Not Related No relationship between the event, including laboratory test abnormality, and the administration of study drug. There is no temporal relationship and there is unambiguous evidence supporting another cause. Unlikely Related A clinical event, including laboratory test abnormality, with a temporal relationship to study drug administration which makes a causal relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations. Possibly Related A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of study drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on study drug withdrawal may be lacking or unclear. Probably Related A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of study drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal of study drug. The association of the clinical event, including laboratory test abnormality, must also have some biologic plausibility, at least on theoretical grounds. Definitely Related A clinical event, including laboratory test abnormality occurring in a plausible time relationship to study drug administration, and which cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the study drug should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory re-challenge procedure if necessary.
Classification of Adverse Events. Each AE whether serious or nonserious will be classified by the Investigator according to the following rules and definitions.
