7.5. Tremelimumab and Sasanlimab Immunogenicity Assessments In participants receiving tremelimumab, blood samples (approximately 5 mL, to provide at least 2 mL of serum) will be collected to detect anti-drug antibodies (ADA) and neutralizing antibody (NAb) against tremelimumab (~1 mL each of ADA and NAb). Similarly, in participants receiving sasanlimab, blood samples (approximately 5 mL, to provide at least 2 mL of serum) will be collected to detect ADA and NAb against sasanlimab (~1 mL each of ADA and NAb). The sampling schedule is specified in the SOA . Samples will be analyzed using a validated analytical method in compliance with Pfizer SOPs. The ADA sample analysis will follow a tiered approach of screening, confirmation, and titer determination. Only those samples tested positive for ADA will be further tested for NAb. The immunogenicity samples must be processed and shipped as indicated in the instructions provided to the investigator site to maintain sample integrity. Any deviations from the immunogenicity sample handling procedure (eg, sample collection and processing steps, interim storage or shipping conditions), including any actions taken, must be documented and reported to the sponsor. On a case-by-case basis, the Sponsor may make a determination as to whether sample integrity has been compromised. Any deviation from the specified sample handling procedure resulting in compromised sample integrity will be considered a protocol deviation. As part of understanding the immunogenicity of the investigational product, samples may be used for evaluation of the bioanalytical method. CCI PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 102CCI PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 1037.7. Other Assessments 7.7.1. Tumor and Medical HistoryHistory of the participant’s disease under study including details of the primary diagnosis and treatment history will be collected within 28 before the start of treatment. In addition, a history of disease process other than the cancer under study (active or resolved) and concurrent illnesses will be collected. This will also include prior treatments and any current medical treatments for any condition. 8. ADVERSE EVENT REPORTING 8.1. RequirementsThe Table 14 below summarizes the requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Report Form to Pfizer Safety. These requirements are delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure. CCI PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 104Table 14. Requirements for Recording Safety Events on the Case Repor t Form (CRF) and Reporting Safety Events on the Clinical Trial Serious Adverse Events Form Safety Event Recorded on the CRF Reported on the CT SAE Report Form to Pfizer Safety Within 24Hours of Awareness SAE All All Non-serious AE All None Exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposureAll (regardless of whether associated with an AE), except occupational exposureExposure during pregnancy, exposure via breastfeeding, occupational exposu re (regardless of whether associated with an AE) All observed or volunteered events regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported as described in the following paragraphs. Events listed i n the table above that require reporting to Pfizer Safet y on the CT SAE Report Form within 24 hours of awareness of the event by the investigator are to be reported regardless of whether the event is determined by the investigator to be related to an investigational product under study . In particular, if the SAE is fatal or life -threatening, notification to Pfizer Safety must be made immediately , irrespective of the extent of available event information. This time frame also applies to additional new (fol low-up) information on previously forwarded reports. I n the rare situation that the investigator does not become immediately aware of the occurrence of an event, the investigator must report the event within 24 hours after learning of it and document the time of his/her first awareness of the event. For each event, the investigator must pursue and obtain adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE (see the Serious Adverse Events section below). In addition, the investigator may be requested b y Pfizer Safety to obtain specific follow -up information in an expedited fashion. This information is more detailed than that recorded on the CRF . In general, this will include a description of the event in sufficient detail to allow for a complete medical assessment of the case and independent determination of possible causalit y. An y information rele vant to the event, such as concomitant medications and illnesses, must be provided. I n the case of a participant death, a summary of available autopsy findings must be submitted as soon as possible to Pfizer Safety . Any pertinent additional information m ust be reported on the CT SAE Report Form; additional source documents (eg, medical records, CRF, laboratory data) are to be sent to Pfizer Safety ONLY upon request. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 105As part of ongoing safet y reviews conducted b y the sponsor, an y non -serious AE that is determined b y the sponsor to be serious will be reported by the sponsor as an SAE. To assist in the determination of case seriousness, further information may be requested from the investigator to provide clarity and understanding of the event in the context of the clinical study . 8.1.1. Additional Details On Recording Adverse Events on the CRF All events detailed in the table above will be recorded on the AE page(s) of the CRF. I t should be noted that the CT SAE Report Form for reporting of SAE information is not the same as the AE page of the CRF. When the same data are collected, the forms must be completed in a consistent manner. AEs should be recorded using concise medical terminology and the same AE term should be used on both the CRF and the CT SAE Report Form for reporting of SAE information. 8.1.2. Eliciting Adverse Event Information The investigator is to record on the CRF all directly observed AEs and all AEs spontaneously reported b y the stud y participant or legally acceptable representative. In addition, eac h study participant/legall y acceptable representative will be questioned about the occurrence of AEs in a non -leading manner. 8.1.3. Withdrawal From the Study Due to Adverse Events (see also the Participant Withdrawal Section) Withdrawal due to AEs should be distinguished from withdrawal due to other causes, according to the definition of AE noted below, and recorded on the CRF. When a participant withdraws from the stud y because of an SAE, the SAE must be recorded on the CRF and reported, as appropriate, on the CT SAE Report Form, in accordance with the Requirements section above. 8.1.4. Time P eriod for Collecting AE/SAE Information The time period for actively eliciting and collecting AEs and SAEs (“active collection period”) for each participant begins from the time the participant provides informed consent, which is obtained before the partic ipant’s participation in the study (ie, before undergoing any study -related procedure and/or receiving investigational product), through and including a minimum of 6 months; except as indicated below after the last administration of the investigational pro duct. For participants who are screen failures, the active collection period ends when screen failure status is determined. 8.1.4.1. Reporting SAEs to Pfizer Safety All SAEs occurring in a participant during the active collection period are reported to Pfizer Safet y on the CT SAE Report Form. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 106SAEs occurring in a participant after the active collection period has ended are reported to Pfizer Safety if the investigator becomes aware of them; at a minimum, all SAEs that the investigator believes have at least a reasona ble possibility of being related to investigational product must be reported to Pfizer Safety . Follow up by the investigator continues throughout and after the active collection period and until the event or its sequelae resolve or stabilize at a level acc eptable to the investigator, and Pfizer concurs with that assessment. If a participant begins a new anticancer therap y, SAEs occurring during the above- indicated active collection period must still be reported to Pfizer Safety irrespective of any interveni ng treatment. 8.1.4.2. Recording Non -serious AEs and SAEs on the CRF During the active collection period, both non-serious AEs and SAEs are recorded on the CRF. Follow -up by the investigator may be required until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment. If a participant begins a new anticancer therap y, the recording period for non -serious AEs ends at the time the new treatment is started; however, SAEs must continue to be recor ded on the CRF during the above-indicated active collection period. 8.1.5. Causality Assessment The investigator’s assessment of causalit y must be provided for all AEs (serious and non-serious); the investigator must record the causal relationship on the CRF, and report such an assessment in accordance with the SAE reporting requirements, if applicable. An investigator’s causalit y assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contribute d to an AE; generall y the facts (evidence) or arguments to suggest a causal relationship should be provided. If the investigator does not know whether or not the investigational product caused the event, then the event will be handled as “related to inves tigational product” for reporting purposes, as defined b y the sponsor. If the investigator’s causality assessment is “unknown but not related” to investigational product, this should be clearl y documented on study records. In addition, if the investigato r determines that an SAE is associated with study procedures, the investigator must record this causal relationship in the source documents and CRF, and report such an assessment in the dedicated section of the CT SAE Report Form and in accordance with the SAE reporting requirements. 8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities AE reporting, including suspected unexpected serious adverse reactions will be carried out in accordance with applicable local regulations. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 1078.2.Definitions 8.2.1. Adverse Events An AE is an y untoward medical occurrence in a study participant administered a product or medical device; the event need not necessaril y have a causal relationship with the treatment or usage. Examples of AEs include, but are not limited to: Abnormal tes t findings; Clinically significant signs and sy mptoms; Changes in ph ysical examination findings; Hypersensitivity ; Drug abuse; Drug dependency . Additionally , AEs may include signs and s ymptoms resulting from: Drug overdose; Drug withdrawal; Drug misuse; Drug interactions; Extravasation; Exposure during pregnancy (EDP); Exposure via breastfeeding; Medication error; Occupational exposure. Worsening of signs and symptoms of the malignancy under study should be recorded as AEs in the appropriate section of th e CRF. Disease progression assessed b y measurement of malignant lesions on radiographs or other methods should not be reported as AEs. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 1088.2.2. Abnormal Test Findings Abnormal objective test findings should be recorded as AEs when an y of the following conditions are met: Test result is associated with accompan ying symptoms; and/or Test result requires additional diagnostic testing or medical/surgical intervention; and/or Test result leads to a change in stud y dosing (outside of an y protocol -specified dose adjust ments) or discontinuation from the study , significant additional concomitant drug treatment, or other therap y; and/or Test result is considered to be an AE b y the investigator or sponsor. Merel y repeating an abnormal test, in the absence of an y of the abov e conditions, does not constitute an AE. An y abnormal test result that is determined to be an error does not require recording as an AE. 8.2.3. Serious Adverse Events A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life -threatening (immediate risk of death); Requires inparticipant hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability /incapacity (substantial disruption of the ability to conduct normal life func tions); Results in congenital anomaly /birth defect. Or that is considered to be: An important medical event. Medical and scientific judgment is exercised in determining whether an event is an important medical event. An important medical event may not be immediately life-threatening and/or result in death or hospitalization. However, if it is determined that the event may jeopardize the participant or may require intervention to prevent one of the other AE outcomes, the important medical event should be r eported as serious. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 109Progressi on of the malignancy under stud y (including signs and s ymptoms of progression) should not be reported as an SAE unless the outcome is fatal within the active collection period. Hospitalization due to signs and s ymptoms of disease progression should not be reported as an SAE. If the malignancy has a fatal outcome during the study or within the active collection period, then the event leading to death must be recorded as an AE on the CRF and as an SAE with Common Terminology Criteria for Adverse Events (CTC AE) Grade 5 (see the Severit y Assessment section). Medical device complaints may meet the SAE reporting requirement criteria (see the Medical Device Complaint Reporting Requirements section). An incident is any malfunction (ie, the failure of a device to meet its performance specifications or to perform as intended; performance specifications include all claims made in the labeling for the device) that, directly or indirectl y, might lead to or might have led to the death of a participant, or user, or of other persons, or to a serious deterioration in their state of health. A serious injury that can cause a serious deterioration in state of health can include: A life -threatening illn ess, even if temporary in nature; A permanent impairment of a bod y function or permanent damage to a body structure; A condition necessitating medical or surgical intervention to prevent the above 2bulleted items; Examples: clinically relevant increase i n the duration of a surgical procedure; a condition that requires hospitalization or significant prolongation of existing hospitalization; Any indirect harm as a consequence of an incorrect diagnostic or in vitro diagnostic device test results when used wi thin the manufacturer’s instructions for use; Fetal distress, fetal death, or an y congenital abnormality or birth defects. 8.2.4. Hospitalization Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility , or any prolongation of an existing admission. Admission also includes transfer within the hospital to an acute/intensive care unit (eg, from the psy chiatric wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a tuberculosis unit). An emergency room visit does not necessarily constitute a hospitalization; however, the event leading to the emergency room visit is assessed for medical importance. Hospitalization does not include the following: Rehabilitation fac ilities; PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 110Hospice facilities; Respite care (eg, caregiver relief); Skilled nursing facilities; Nursing homes; Same -day surgeries (as outpatient/same -day/ambulatory procedures). Hospitalization or prolongation of hospitalization in the absence of a precipitating clinical AE is not in itself an SAE. Examples include: Admission for treatment of a preexisting condition not associated with the development of a new AE or with a worse ning of the preexisting condition (eg, for workup of a persistent pretreatment laboratory abnormality ); Social admission (eg, participant has no place to sleep); Administrative admission (eg, for yearly physical examination); Protocol -specified admission during a stud y (eg, for a procedure required by the stud y protocol); Optional admission not associated with a precipitating clinical AE (eg, for elective cosmetic surgery ); Hospitalization for observation without a medical AE; Preplanned treatments or surgical procedures. These should be noted in the baseline documentation for the entire protocol and/or for the individual participant; Admission exclusively for the administration of blood products. Diagnostic and therapeutic noninvasive and invasive procedur es, such as surgery , should not be reported as SAEs. However, the medical condition for which the procedure was performed should be reported if it meets the definition of an SAE. For example, an acute appendicitis that begins during the reporting period should be reported if the SAE requirements are met, and the resulting appendectomy should be recorded as treatment of the AE. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 1118.3.Severity Assessment Table 15.Clinical Description of Severity GRADE Clinical Description of Severity 0 No change from normal or reference range (This grade is not included in the Version 5.0 CTCAE document but may be used in certain circumstances). 1 MILD adverse event 2 MODERATE adverse event 3 SEVERE adverse event 4 LIFE -THREATENING consequences; urgent intervention indicated 5 DEATH RELATED TO adverse event Note the distinction between the severit y and the seriousness of an AE. A severe event is not necessarily an SAE. For example, a headache may be severe (interferes significantly with the participant’s usual function) but would not be classified as serious unless it met one of the criteria for SAEs, listed above. 8.4.Special Situations 8.4.1. Potential Cases of Drug- Induced Liver Injury Humans exposed to a drug who show no sign of liver injury (as det ermined by elevations in transaminases) are termed “tolerators,” while those who show transient liver injury , but adapt are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a more serious potential outcome. These participants fail to adapt and therefore are “susceptible” to progressive and serious liver injury , commonl y referred to as drug -induced liver injury (DILI). Participants who experience a transaminase elevation above 3 times the upper limit of normal ( ×ULN) sh ould be monitored more frequently to determine if they are an “adaptor” or are “susceptible.” In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) precede total bilirubin (Tbili) elevations (>2 ×ULN) by several day s or weeks. The increase in Tbili ty pically occurs while AST/AL T is/are still elevated above 3×ULN (ie, AST/ALT and Tbili values will be elevated within the same lab sample). In rare instances, b y the time Tbili elevations are det ected, AST/ALT values might have decreased. This occurrence is still regarded as a potential DILI. Therefore, abnormal elevations in either AST OR AL T in addition to Tbili that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law criteria) cases and should alway s be considered important medical events, even before all other possible causes of liver injury have been excluded. The threshold of laboratory abnormalities for a potential DILI case depends on the participant’s in dividual baseline values and underly ing conditions. Participants who present PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 112with the following laboratory abnormalities should be evaluated further as potential DILI (Hy’s law) cases to definitively determine the etiology of the abnormal laboratory value s: Participants with AST/ALT and Tbili baseline values within the normal range who subsequently present with AST OR AL T values >3 ×ULN AND a Tbili value >2× ULN with no evidence of hemol ysis and an alkaline phosphatase value <2×ULN or not available; For participants with baseline AST OR ALT ORTbili values above the ULN, the following threshold values are used in the definition mentioned above, as needed, depending on which values are above the ULN at baseline: Preexisting AST or ALT baseline values abo ve the normal range: AST or ALT values >2 times the baseline values AND >3 ×ULN; or >8 ×ULN (whichever is smaller). Preexisting values of Tbili above the normal range: Tbili level increased from baseline value b y an amount of at least 1 × ULN orif the v alue reaches >3×ULN (whichever is smaller). Rises in AST/AL T and Tbili separated b y more than a few weeks should be assessed individually based on clinical judgment; any case where uncertainty remains as to whether it represents a potential Hy’s law case should be reviewed with the sponsor. The participant should return to the I nvestigator site and be evaluated as soon as possible, preferabl y within 48 hours from awareness of the abnormal results. This evaluation should include laboratory tests, detaile d history , and physical assessment. The possibility of hepatic neoplasia (primary or secondary ) should be considered. In addition to repeating measurements of AST and AL T and Tbili, laboratory tests should include albumin, creatine kinase (CK), direct and indirect bilirubin, gamma -glutam yl transferase (GGT), prothrombin time (PT)/international normalized ratio (INR), total bile acids, alkaline phosphatase and acetaminophen drug and/or protein adduct levels. Consideration should also be given to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further testing, as needed, for further contemporaneous analy ses at the time of the recognized initial abnormalities to determine etiology . A detailed history , including relevant infor mation, such as review of ethanol, acetaminophen (either b y itself or as a coformulated product in prescription or over -the-counter medications), recreational drug, supplement (herbal) use and consumption, family history , sexual history , travel history , history of contact with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and potential occupational exposure to chemicals, should be collected. Further testing for acute hepatitis A, B, C, D, and E infection and liver im aging (eg, biliary tract) may be warranted. All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/AL T and Tbili elevation defined above should be considered potential DILI (Hy ’s law) cases if no other reason for the LFT abnorm alities has yet been found. Such potential DILI (Hy’s law) PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 113cases are to be reported as SAEs, irrespective of availability of all the results of the investigations performed to determine etiology of the LFT abnormalities. A potential DILI (Hy ’s law) case becomes a confirmed case onl y after all results of reasonable investigations have been received and have excluded an alternative etiology . 8.4.2. Exposure to the Investigational Product During Pregnancy or Breastfeeding, and Occupational Exposure Exposure to the investigational product under study during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of investigator awareness. 8.4.2.1. Exposure During Pregnancy (EDP) For both unapproved/unlicensed products and for marketed products, an EDP occurs if: A female becomes, or is found to be, pregnant either while receiving or having been exposed (eg, because of treatment or environmental exposure) to the investigational product; or the female becomes or is found to be pr egnant after discontinuing and/or being exposed to the investigational product; An example of environmental exposure would be a case involving direct contact with a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has been e xposed to chemotherapeutic products). A male has been exposed (eg, because of treatment or environmental exposure) to the investigational product prior to or around the time of conception and/or is exposed during his partner’s pregnancy . If a participant o r participant’s partner becomes or is found to be pregnant during the participant’s treatment with the investigational product, the investigator must report this information to Pfizer Safety on the CT SAE Report Form and an EDP supplemental form, regardles s of whether an SAE has occurred. In addition, the investigator must submit information regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a participant reports that she is pregnant and has been exposed to a cytotoxic product b y inhalation or spillage) to Pfizer Safety using the EDP supplemental form. This must be done irrespective of whether an AE has occurred and within 24 hours of awareness of the exposure. The information submitted should include the anticipated date of del ivery (see below for information related to termination of pregnancy ). Follow -up is conducted to obtain general information on the pregnancy and its outcome for all EDP reports with an unknown outcome. The investigator will follow the pregnancy until completion (or until pregnancy termination) and notify Pfizer Safet y of the outcome as a follow -up to the initial EDP supplemental form. In the case of a live birth, the structural integrit y of the neonate can be assessed at the time of birth. In the event o f a termination, the reason(s) for termination should be specified and, if clinically possible, the structural PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 114integrit y of the terminated fetus should be assessed by gross visual inspection (unless pre-procedure test findings are conclusive for a congenit al anomal y and the findings are reported). If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy , spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomal y [in a live-born bab y, a terminated fetus , an intrauterine fetal demise, or a neonatal death]), the investigator should follow the procedures for reporting SAEs. Additional information about pregnancy outcomes that are reported to Pfizer Safet y as SAEs follows: Spontaneous abortion includes misc arriage and missed abortion; Neonatal deaths that occur within 1 month of birth should be reported, without regard to causality , as SAEs. In addition, infant deaths after 1 month should be reported as SAEs when the investigator assesses the infant death a s related or possibly related to exposure to the investigational product. Additional information regarding the EDP may be requested by the sponsor. Further follow -up of birth outcomes will be handled on a case- by-case basis (eg, follow -up on preterm infa nts to identify developmental delay s). In the case of paternal exposure, the investigator will provide the participant with the Pregnant Partner Release of Information Form to deliver to his partner. The investigator must document in the source documents that the participant was given the Pregnant Partner Release of Information Form to provide to his partner. 8.4.2.2. Exposure During Breastfeeding Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of an associated SAE, to Pfi zer Safet y within 24 hours of the investigator’s awareness, using the CT SAE Report Form. An exposure during breastfeeding report is not created when a Pfizer drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in accord with authorized use. However, if the infant experiences an SAE associated with such a drug’s administration, the SAE is reported together with the exposure during breastfeeding. 8.4.2.3. Occupational Exposure An occupational exposure occurs when, during the per formance of job duties, a person (whether a healthcare professional or otherwise) gets in unplanned direct contact with the product, which may or may not lead to the occurrence of an AE. An occupational exposure is reported to Pfizer Safety within 24 hours of the investigator’s awareness, using the CT SAE Report Form, regardless of whether there is an associated SAE. Since the information does not pertain to a participant enrolled in the study , the information is not recorded on a CRF; however, a copy of the completed CT SAE Report Form is maintained in the investigator site file. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 1158.4.3. Medication Errors Other exposures to the investigational product under study may occur in clinical trial settings, such as medication errors. (see Table 16). Table 16. Medication Errors Reporting on the Clinical Trial Serious Adverse Event Form Safety Event Recorded on the CRF Reported on the CT SAE Report Form to Pfizer Safety Within 24 Hours of Awareness Medication errors All (regardless of whether associated with an AE)Only if associated with an SAE 8.4.3.1. Medication Errors Medication errors may result from the administration or consumption of the investigational product b y the wrong participant, or at the wrong time, or based on the investigational product administration, such as inadvertent exposure, or at the wrong dosage strength. Medication errors include : Medication errors involving participant exposure to the investigational product; Potential medication errors or uses outside of what is foreseen in the protocol that do or do not involve the participating participant. Such medication errors occurring to a stud y participant are to be captured on the medication error page of the CRF, which is a specific version of the AE page. In the event of medication dosing error, the sponsor should be notified within 24 hours. Whether or not the medication error is accompanied by an AE, as determined by the investigator, the medication error is recorded on the medication error page of the CRF and, if applicable, an y associated AE(s), serious and non -serious, are recorded on an AE page of the CRF. Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report Form only when associated with an SAE . 8.5.Medical Device Complaint Reporting Requirements All medical device complaints, regardless of whether the medical device complaint is associated with an AE, will be recorded on the applicable pages within the CRF. This includes potential incidents or malfunctions associated with the use of a medical device PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 116product. An incident or malfunction is an event that might have led to death or serious deterioration in health, or if it occurred again might lead to death or serious deterioration in health. Pfizer is to be notified of all medical device complaints within 24 hours of the investigator’s awareness of the event. 9. DATA ANALYSIS/STATISTICAL METHODS Detailed methodology for summary and statistical analyses of the data collected in this study is outlined here and further detailed in a statistical analysis plan (SAP), which will be maintained by the sponsor. The SAP may modify what is outlined in the protocol where appropriate; however, any major modifications of the primary endpoint definitions or their analyses will also be reflected in a protocol amendment. 9.1. Analysis Sets For safety evaluation, participants should have received at least one of the regimen components. For efficacy evaluation, participants should have received at least one dose of all components administered on Cycle 1 Day 1. See Section 9.4 for definitions related to efficacy. Participants who receive the designated investigational product of interest and have at least one post-dose drug concentration measurement will be included in the PK data analysis. 1. Safety analysis set. The safety analysis set includes all enrolled participants who receive at least one dose of one of the components of the regimen. 2. Full analysis set. The full analysis set includes all enrolled participants. 3.Per protocol analysis set . The per protocol (PP) analysis set includes all enrolled participants who receive at least one dose of all regimen components administered on Cycle 1 Day 1 of study medication and who do not have major protocol deviations during the 28 days after the first vaccination. 4. Modified Intention-to-Treat analysis set. modified Intention-to-Treat (mITT), which is defined as all enrolled participants who received at least one dose of all regimen components administered on Cycle 1 Day 1. a participant CCI CCI CCI PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 117must have at least 1 valid and determinate assay result related to the proposed analysis. Participants who have no valid and determinate assay result related to any proposed analysis will be excluded from the mITT analysis set. 5.PK analysis set. The PK parameter analysis population is defined as all enrolled participants treated who have sufficient information to estimate at least 1 of the PK parameters of interest and who have no major protocol deviations influencing the PK assessment. 6. Immunogenicity analysis set. The immunogenicity analysis set includes all enrolled participants who receive at least one dose of the VBIR-2 component that is the subject of the immunogenicity assessment (tremelimumab or sasanlimab). 9.2.