Fatal: Event caused the death of the pati ent. Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 42 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page Adverse events will be followed until resolution or stabilization while the patient remains on-study. Once the patient is removed from study, events thought to be related to the study medication will be followed until resolution or stabilization, unless, in the Investigator’s opinion the event is unlikely to resolve due to the patient’s underlying disease, or until the patient starts a new treatment regimen or the patient is lost to follow -up. 8.1.2.2 Attribution Definitions An adverse event is considered to be associated with the use of the Investigational Product if the attribution is determined as possible or definite. Attribution of AEs will be recorded in the CRF as: • Unrelated: The AE is clearly NOT related to the study treatment. • Possible: The AE may be related to the study treatment. • Definite: The AE is clearly related to the study treatment. 8.1.2.3 Definition of an Unexpected Adverse Event An unexpected adverse event is defined as any adverse drug experience, the specificity or severity of which is not co nsistent with the current Investigator Brochure; or, if an Investigator Brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in this protocol or in the regulatory agency study aut horization application. Unexpected, as used in this definition, refers to an adverse drug experience that has not been previously observed (e.g., included in the Investigator Brochure) rather than from the perspective of such experience not being antici pated from the pharmacological properties of the pharmaceutical product. 8.1.2.4 Serious Adverse Event (SAE) A serious adverse event is defined as any untoward medical occurrence that at any dose: 1. Results in death, 2.