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14 conduct of the study

The study will be conducted in accordance the appropriate regulatory requirement(s). Essential clinical documents are maintained to demonstrate the validity of the study and the integrity of the data collected. Master files should be established at the beginning of the study, maintained for the duration of the study and retained according to the appropriate regulations.
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14.2 ethical considerations

The study will be conducted in accordance with ethical principles founded in the Declaration of Helsinki. The IRB will review all appropriate study documentation in order to safeguard the rights, safety and well-being of the patients. The study will only be conducted at sites where IRB approval has been obtained. The protocol, consent, written information given to the patients, safety updates, progress reports, and any revisions to these documents will be provided to the IRB by the Investigator.
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15 references

1. Chiorean EG, DeFor TE, Weisdorf, DJ, et al. Donor Chimerism Does Not Predict Resonse to Donor Lymphocyte Infusion for Relapsed Chronic Myelogenous Leukemia After Allogeneic Hematopoetic Cell Transplantation. Biol Blood Marrow Transplant 2004 Mar 10 (3) 171-7.  
2. Warlick ED, Defor T, Blazar BR, et al. Successful remission rates and survival after lymphodepleting chemotherapy and donor lymphocyte infusion for relapsed hematologic malignancies postallogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2012 Mar; 18(3): 480–486.  
3. Miller JS, Warren EH, van den Brink MR, et al. NCI First International Workshop on The Biology, Prevention, and Treatment of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: Report from the Committee on the Biology Underlying Recurrence of Malignant Disease following Allogeneic HSCT: Graft-versus-Tumor/Leukemia Reaction. Biol Blood Marrow Transplant. 2010 16(5) 565-86.  
4. Bryceson, YT, March ME, Ljunggren HG, et al. Activation, coactivation, and costimulation of resting human natural killer cells. Immunol Rev. 2006 Dec;214:73-91.  
5. Koh CY, Blazar BR, George T, et al. Augmentation of antitumor effects by NK cell inhibitory receptor blockade in vitro and in vivo, Blood 2001 May 15;97(10):3132-7.  
6. Lanier LL. NK cell recognition. Annu Rev Immunol 2005;23:225-74. 7. Cheever MA. Twelve immunotherapy drugs that could cure cancers. Immunol Rev.  
2008;222:357-368.  
8. Steel JC, Waldmann TA, Morris JC. Interleukin-15 biology and its therapeutic implications in cancer. Trends Pharmacol Sci. 2012;33(1):35-41.  
9. Sato N, Patel HJ, Waldmann TA, Tagaya Y. The IL-15/IL-15Ralpha on cell surfaces enables sustained IL-15 activity and contributes to the long survival of CD8 memory T cells. Proc Natl Acad Sci U S A. 2007;104(2):588-593.  
10. Zhu X, Marcus W, Xu W, et al. Novel Human Interleukin-15 Agonists. J of Immunology, 2009, 183(6): 3598–3607.  
11. Han KP, Zhu X, Liu B, et al. IL-15:IL-15 receptor alpha superagonist complex: High-level coexpression in recombinant mammalian cells, purification and characterization. Cytokine.  
2011;56(3):804-810.  
12. Devine SM, Owzar K, Blum W, et al. Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a ReducedIntensity Conditioning Regimen: Results From Cancer and Leukemia Group B. Clin Oncol.  
2015 Dec 10; 33(35):4167-75.  
13. Scott BL, Pasquini MC, Logan BR et al. Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2017 Apr 10;35(11):1154-1161.  
14. Sengsayadeth S, Savani BN, Blaise D, et al. Reduced intensity conditioning allogeneic hematopoietic cell transplantation for adult acute myeloid leukemia in complete remission - a review from the Acute Leukemia Working Party of the EBMT. Haematologica. 2015 Jul;100(7):859-69.
15. Romee R, Cooley S, Berrien-Elliott MM, et al. First-in-human phase 1 clinical study of the IL15 superagonist complex ALT-803 to treat relapse after transplantation. Blood. 2018 Jun 7;131(23):2515-2527.  
16. Felices M, Lenvik AJ, McElmurry R, et al. Continuous treatment with IL-15 exhausts human NK
cells via a metabolic defect. JCI Insight. 2018;3(3):e96219.  
17. Deleted with the July 2020 revision - Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124(2):188-195.  
18. Lin DY. Non-parametric inference for cumulative incidence functions in competing risks studies.  
Stat Med 1997;16(8):901-10.  
19. Kaplan EL, Meier P. Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association. 1958;53(282):457-81.  
20. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. Hoboken, NJ, USA:
John Wiley and Sons; 1980.  
21. Ivanova I, Qaqish BF, Schell MJ. Continuous toxicity monitoring in phase II trials in Oncology.  
Biometrics 2005, 61: 540-545.  
Appendix I - Karnofsky PS and NYHA Classification  
Karnofsky Performance Status Scale  
| Karnofsky Performance Status Scale  100  Normal no complaints; no evidence of  disease.                               |                                                                                  |                                                                        |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Able to carry on normal activity and to work;  no special care needed.                                                | 90                                                                               | Able to carry on normal activity; minor  signs or symptoms of disease. |
| 80                                                                                                                    | Normal activity with effort; some signs  or symptoms of disease.                 |                                                                        |
| 70                                                                                                                    | Cares for self; unable to carry on  normal activity or to do active work.        |                                                                        |
| Unable to work; able to live at home and  care for most personal needs; varying  amount of assistance needed.         | Requires occasional assistance, but is                                           |                                                                        |
| 60                                                                                                                    | able to care for most of his personal  needs.                                    |                                                                        |
| 50                                                                                                                    | Requires considerable assistance and  frequent medical care.                     |                                                                        |
| 40                                                                                                                    | Disabled; requires special care and  assistance.                                 |                                                                        |
| 30                                                                                                                    | Severely disabled; hospital admission is  indicated although death not imminent. |                                                                        |
| Unable to care for self; requires equivalent  of institutional or hospital care; disease may  be progressing rapidly. | Very sick; hospital admission                                                    |                                                                        |
| 20                                                                                                                    | necessary; active supportive treatment  necessary.                               |                                                                        |
| 10                                                                                                                    | Moribund; fatal processes progressing  rapidly.                                  |                                                                        |
| 0                                                                                                                     | Dead                                                                             |                                                                        |  
Ref: Karnofsky DA, Burchenal JH. (1949). "The Clinical Evaluation of Chemotherapeutic Agents in Cancer." In: MacLeod CM (Ed), *Evaluation of Chemotherapeutic Agents.* Columbia Univ Press. Page 196.  
| New York Heart Association Functional Classification   |                                                                                                                                                                                                 |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NYHA  Class                                            | Symptoms                                                                                                                                                                                        |
| I                                                      | Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g.  shortness of breath when walking, climbing stairs etc.                                                  |
| II                                                     | Mild symptoms (mild shortness of breath and/or angina) and slight limitation during  ordinary activity. Marked limitation in activity due to symptoms, even during less-than-ordinary activity, |
| III                                                    | e.g. walking short distances (20–100 m). Comfortable only at rest.                                                                                                                              |
| IV                                                     | Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.                                                                                                          |  
Ref: The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
appendix ii - disease specific
modified recist complete remission (cr)

CR requires that all of the following be present.  
- Peripheral Blood Counts o ANC count > 1,000/mm3 o Platelet count > 100,000/ mm3 o Reduced hemoglobin concentration or hematocrit has no bearing on remission status. o Leukemic blasts must not be present in the peripheral blood
- Marrow Aspirate and Biopsy o Bone marrow biopsy must demonstrate trilineage hematopoiesis with maturation of all cell lines.  
o < 5% blasts
- Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
appendix ii - disease specific
morphological remission (mr)

MR requires that the following be present:
- Patient meets all peripheral blood and bone marrow criteria for CR, except that platelet count is < 100,000/mm3 but > 50,000/mm3.
appendix ii - disease specific
relapse

Relapse following CR is defined as:
- Peripheral Blood Counts Presence of peripheral blasts. A bone marrow examination must be performed to confirm relapse. However, please note that the date of relapse is the first date at which the relapsed patient had: leukemic blasts in the peripheral blood smear, or >5% blasts in the bone marrow.  
- Bone Marrow Aspirate or Biopsy Presence of more than 5% blasts, not attributable to another cause (e.g., bone marrow regeneration).
appendix ii - disease specific
myelodysplastic syndromes (mds) response criteria

Based on International Working Group 2006 Modified Criteria
- Complete Remission (CR): < 5% myeloblasts with normal maturation of all cell lines o Persistent dysplasia will be noted o Peripheral Blood:
- Hgb > 11g/dl
- Platelets > 100 X 109 /L
- Neutrophils > 1000 - Blasts = 0%
- Partial Remission (PR): all CR criteria if abnormal before except:
o BM blasts decreased by > 50% over pre-treatment but still >5%
- Marrow CR: Bone marrow with < 5% myeloblasts and decrease by >50% over pretreatment with incomplete peripheral blood count normalization
- Hematologic Improvement (HI):
o Hgb: Increase by > 1.5g/dl or decreased PRBC transfusions by at least 4/8 week period (only PRBC given for Hgb<9.0g/dl)
o Platelet Response: Absolute increase of > 30 X 109/L for those starting at >20 X 109/L
For those < 20 X 109/L at baseline increase by 100%.  
o Neutrophil Response: at least 100% increase and an absolute increase of >0.5 X
109/L
- Stable Disease: Failure to achieve at least a PR but no evidence of disease progression for
>8 weeks
- Failure: Death during treatment or disease progression characterized by worsening cytopenias, increase percentage of marrow blasts, or progression to a more advanced MDS FAB subtype
- Cytogenetic Response:
o Complete: Disappearance of any pre-treatment chromosomal abnormalities without the appearance of new ones o Partial: At least 50% reduction of chromosomal abnormality
- Disease Progression: Compared to pre-treatment values o Less than 5% blasts: greater than 50% increase to >5% blasts o 5-10% blasts: greater than 50% increase to >10% blasts o 10-20% blasts: greater than 50% increase to >20% blasts
appendix ii - disease specific
appendix iii- gvhd grading scales

| Consensus Clinical Stage and Grade of Acute GVHD (Glucksberg et al, 1974; Thomas et al, 1975, Przepiorka et al, 1995) Stage Skin Liver Lower Gastrointestinal  Upper  Tract Gastrointestinal  Tract 1 Maculopapular rash  Bilirubin 2.0 - 3.0  Diarrhea 500 - 1000  <25% of body surface mg/dl mL/day or 280 - 555  mL/m2 No protracted nausea  and vomiting 2 Maculopapular rash  Bilirubin 3.1 - 6.0  Diarrhea 1000 - 1500  25-50% body surface mg/dl mL/day or 556 - 833  mL/m2 Persistent nausea,  vomiting or anorexia 3 Generalized  Bilirubin 6.1 - 15.0  Diarrhea >1500 mL/day  erythroderma mg/dl or >833 mL/m2 4 Generalized  erythroderma with  bullous formation and  desquamation Bilirubin > 15 mg/dl Severe abdominal pain,  with or without ileus, or  stool with frank blood or  melena   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
| University Of Minnesota Acute GVHD Grading                 |            |             |                |                |
|------------------------------------------------------------|------------|-------------|----------------|----------------|
| Acute GVHD Grade                                           | Skin Stage | Liver Stage | Lower GI Stage | Upper GI Stage |
| I                                                          | 1-2        | 0           | 0              | 0              |
| II                                                         | 3          | 1           | 1              | 1              |
| III                                                        | -          | 2-4         | 2-3            |                |
| IV                                                         | 4          | -           | 4              |                |
| - Each column identifies minimum criteria for organ grade. |            |             |                |                |
appendix ii - disease specific
late acute and chronic gvhd

Late acute and chronic GVHD will be assessed using the National Institutes of Health (NIH) Consensus Criteria.  
Patient ID:
Date of late acute or chronic GVHD diagnosis (mm/dd/yyyy) / /
Onset of chronic GVHD was:
Progressive (acute GVHD progressed directly to chronic GVHD) Interrupted (acute GVHD resolved, then chronic GVHD developed) De novo (acute GVHD never developed)
Chronic GVHD flare (symptoms reactivated within 30 days of drug tapering or discontinuation)
appendix ii - disease specific
karnofsky performance status

100 Normal, no complaints; no evidence of disease 90 Able to carry on normal activity, minor signs or symptoms of disease 80 Normal activity with effort; some signs or symptoms of disease 70 Cares for self; unable to carry on normal activity or do active work 60 Requires occasional assistance, but is able to care for most of his/her needs 50 Requires considerable assistance and frequent medical care 40 Disabled; requires special care and assistance 30 Severely disabled; hospitalization is indicated. Death not imminent 20 Very Sick, hospitalization necessary, active supportive treatment necessary 10 Moribund, fatal processes, progressing rapidly 0 Dead
appendix ii - disease specific
diagnosis was based on

Histologic evidence / biopsy proven Clinical evidence Both Unknown Maximum grade of chronic GVHD
Limited Extensive
appendix ii - disease specific
overall severity of chronic gvhd

Organ/System Involvement (check if yes)
Sclerosis of skin Other skin or hair involvement (rash, ulcers, pruritus or itching, dyspigmentation, alopecia, lichenoid skin changes, etc)
Eyes (xerophthalmia (dry eyes), abnormal Schirmer's test, abnormal slit lamp, corneal erosion /
conjunctivitis, etc)
Mouth (lichenoid changes, mucositis / ulcers, erythema, etc)
Bronchiolitis obliterans Other lung involvement Organ/System Involvement (check if yes)
Gastrointestinal tract (esophageal involvement, chronic nausea / vomiting, chronic diarrhea, malabsorption, abdominal pain / cramps, etc)
Liver Genitourinary tract (vaginitis / stricture, etc) Musculoskeletal (arthritis, contractures, myositis, myasthenia, etc)
Thrombocytopenia (< 100 x 10^9/L) Eosinophilia Autoantibodies Other hematologic involvement Serositis Weight loss Other organ involvement from chronic GVHD
Specify other organ:
Ref: Jagasia MH, Greinix HT, Arora M. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: The 2014 Diagnosis and Staging Working Group Report. Biol Blood Marrow Transplant. 2015 March; 21(3): 389–
Appendix IV - N-803 **Targeted Toxicity Worksheet**
MT2016-07 CTCAE v4 Refer to Section 10.2 for time points Patient Initials: _______ **Date of Assessment:** _________ **Assessment Time point:** _________  
| Patient Initials: _______                          | Date of Assessment: _________                                                   | Assessment Time point: _________                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                               |                                      |                                 |
|----------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------|
| Toxicity                                           | Grade 0                                                                         | Grade 1                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Grade 2                                                                                                                                                       | Grade 3                              | Grade 4                         |
| None                                               | Tenderness with or                                                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| N-803 Injection                                    | without associated                                                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| site reaction                                      | symptoms (e.g., warmth,  erythema, itching)                                     | Pain; lipodystrophy; edema;                                                                                                                                                                                                                                                                                                                                                                                                                                          | Ulceration or necrosis; severe                                                                                                                                | Life-threatening consequences;       |                                 |
| phlebitis                                          | tissue damage; operative                                                        | urgent intervention indicated                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                               |                                      |                                 |
| intervention indicated                             |                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Dyspnea                                            | None or                                                                         | Shortness of breath with                                                                                                                                                                                                                                                                                                                                                                                                                                             | Shortness of breath with minimal                                                                                                                              | Shortness of breath at rest;         | Life-threatening consequences;  |
| no change                                          | moderate exertion                                                               | exertion; limiting instrumental ADL                                                                                                                                                                                                                                                                                                                                                                                                                                  | limiting self care ADL                                                                                                                                        | urgent intervention indicated        |                                 |
| None                                               | ………………                                                                          | Decreased O2 saturation with  exercise (e.g., pulse oximeter <                                                                                                                                                                                                                                                                                                                                                                                                       |                                                                                                                                                               |                                      |                                 |
| Hypoxia                                            | 88%) intermittent supplemental  oxygen                                          | Decreased oxygen saturation at                                                                                                                                                                                                                                                                                                                                                                                                                                       | Life-threatening airway                                                                                                                                       |                                      |                                 |
| rest (e.g., pulse oximeter < 88%                   | compromise; urgent                                                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| or PaO2 ≤ 55 mm Hg)                                | intervention indicated (e.g., tracheotomy or intubation)                        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Fever                                              | None                                                                            | 38.0 - 39.0◦ C (100.4 -                                                                                                                                                                                                                                                                                                                                                                                                                                              | > 39.0 - 40.0◦C (102.3 - 104.0◦F)                                                                                                                             | > 40.0 ◦ C (>104.0◦ F) for ≤ 24 hrs  | > 40.0 ◦ C (>104.0◦ F) for > 24 |
| 102.2◦ F)                                          | hrs                                                                             |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Chills                                             | None                                                                            | Mild sensation of cold;                                                                                                                                                                                                                                                                                                                                                                                                                                              | Moderate tremor of the entire body;                                                                                                                           | Severe or prolonged, not             | ………………………                       |
| shivering; chattering of teeth narcotics indicated | responsive to narcotics                                                         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| None                                               | Pre-hypertension (systolic  BP 120 - 139 mm Hg or  diastolic BP 80 - 89 mm  Hg) | Stage 1 hypertension (systolic BP  140 - 159 mm Hg or diastolic BP 90 - 99 mm Hg); medical intervention  indicated; recurrent or persistent ≥  24 hrs); symptomatic increase by  >20 mm Hg (diastolic) or to >140/90  mm Hg if previously WNL;  monotherapy indicated. Stage 2 hypertension (systolic BP  ≥ 160 mm Hg or diastolic BP ≥  100 mm Hg); medical intervention  indicated; more than one drug or  more intensive therapy than  previously used indicated. | Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis); urgent  intervention indicated. |                                      |                                 |
| Hypertension Hypotension                           | None                                                                            | Asymptomatic, intervention                                                                                                                                                                                                                                                                                                                                                                                                                                           | Non-urgent medical                                                                                                                                            | Medical intervention or              | Life-threatening and urgent     |
| not indicated                                      | intervention indicated                                                          | hospitalization indicated                                                                                                                                                                                                                                                                                                                                                                                                                                            | intervention indicated                                                                                                                                        |                                      |                                 |
| None                                               | Localized to dependent                                                          | Moderate localized edema                                                                                                                                                                                                                                                                                                                                                                                                                                             | Severe localized edema and                                                                                                                                    | ………………………                            |                                 |
| Edema                                              | areas, no disability or                                                         | and intervention indicated;                                                                                                                                                                                                                                                                                                                                                                                                                                          | intervention indicated; limiting self                                                                                                                         |                                      |                                 |
| functional impairment                              | limiting instrumental ADL                                                       | care ADL                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                               |                                      |                                 |
| None                                               | Asymptomatic; clinical or  diagnostic observations                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Pneumonitis                                        | only; intervention not  indicated                                               | Symptomatic; medical                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Severe symptoms; limiting self                                                                                                                                | Life-threatening respiratory         |                                 |
| intervention indicated; limiting                   | care ADL; oxygen indicated                                                      | compromise; urgent                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                               |                                      |                                 |
| instrumental ADL                                   | intervention indicated (e.g.  intubation or tracheotomy)                        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Headache                                           | None                                                                            | Mild pain                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Moderate pain; limiting                                                                                                                                       | Severe pain; limiting self care      | ………………………                       |
| instrumental ADL                                   | ADL                                                                             |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Confusion                                          | None                                                                            | Mild disorientation                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Moderate disorientation; limiting                                                                                                                             | Severe disorientation; limiting self | Life-threatening                |
| (Altered Mental                                    | instrumental ADL                                                                | care ADL                                                                                                                                                                                                                                                                                                                                                                                                                                                             | consequences; urgent                                                                                                                                          |                                      |                                 |
| Status)                                            | intervention indicated                                                          |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Rash (outside of                                   | None                                                                            | Covering < 10% body                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Covering 10-30% body surface                                                                                                                                  | >30% body surface area (BSA)         | Generalized exfoliative,        |
| the injection site                                 | surface area (BSA)                                                              | area (BSA)                                                                                                                                                                                                                                                                                                                                                                                                                                                           | ulcerative, or bullous dermatitis                                                                                                                             |                                      |                                 |
| reaction)                                          | None                                                                            | Mild change in gait (eg,                                                                                                                                                                                                                                                                                                                                                                                                                                             | Moderate change in gait (eg, widebased, limping or hobbling);                                                                                                                                                               |                                      |                                 |
| wide-based, limping or                             |                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                               |                                      |                                 |
| Gait Disturbance                                   | hobbling)                                                                       | assistance device indicated;  limiting instrumental ADL                                                                                                                                                                                                                                                                                                                                                                                                              | Disabling; limiting self care ADL                                                                                                                             | ………………………                            |                                 |  
Person Completing Form: ADL = activities of daily living
appendix v - n-803 injection
overall severity of chronic gvhd

The Diary is to be completed by the patient as a self-assessment in association with each dose of N-803.  
A new diary must be started for each N-803 injection. If the injection reaction has not resolved by Day 6 post-injection, continue to collect information on page 2 based on the days from that injection.  
For inpatients, the diary is completed by study personnel.  
Patient Number* Date of Study Drug Injection* **________/_________/________** *To be completed by the site.  
| Please answer all questions below daily for 7 days, beginning with day of treatment. Be sure to bring back this completed diary to your next clinic visit. Day of Study  Instructions Drug Injection ____/____/_________ Day 1 Post Injection ____/____/_________ Day 2 Post Injection ____/____/_________ Day 3 Post Injection ____/____/_________ Day 4 Post Injection ____/____/________ Day 5 Post Injection ___/___/________ Day 6 Post Injection ____/____/_________ Check: Yes or No If yes, measure longest  diameter in cm Yes No Yes No Yes No  Yes No Yes No Yes No Yes No 1. Is there redness at  the injection site? ________cm ________cm ________cm ________cm ________cm ________cm ________cm Check: Yes or No Yes No Yes No Yes No Yes No Yes No Yes No Yes No 2. Is there firmness or  swelling at the  injection site? Check the pain  and/or itch box if  present Indicate if the pain  and/or itching is mild,  moderate or severe  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch 3. Have you  experienced any pain or itching at the  injection site? Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Yes No Yes No Yes No Yes No Yes No Yes No Yes No Name(s): Name(s): Name: Name: Name: Name: Name: 4. Have you taken or  applied any  medication for  injection site pain or  itching? Check: Yes or No Provide name of  medication(s) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Check: Yes or No If yes, circle the worse  severity of the chills: mild, moderate or severe 5. Have you  experienced any  chills?  Mild Moderate  Severe  Mild Moderate  Severe  Mild Moderate  Severe  Mild Moderate  Severe  Mild Moderate  Severe  Mild Moderate  Severe  Mild Moderate  Severe Yes No Yes No Yes No Yes No Yes No Yes No Yes No 6. Record your daily  temperature upon  waking (do not drink anything 5  minutes before taking your  temperature) Check: Yes or No If your temperature is  101°F for more than 24  hours notify your study  doctor or research staff. ________°F ________°F ________°F ________°F ________°F ________°F ________°F Time: ____:____  AM / PM Time: ____:____  AM / PM Time: ____:____  AM / PM Time: ____:____  AM / PM Time: ____:____  AM / PM Time: ____:____  AM / PM Time: ____:____  AM / PM Grading Injection Site Pain or Itching Grading Chills Mild - Noticeable, does not interfere with activity Mild - Mild sensitive of cold, shivering, chattering of teeth Moderate - Interferes with activity, limiting activities of daily living Moderate - Moderate tremor of entire body, medication taken   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
Page 2 - Please continue to complete for Injection Site Reaction if ongoing after page 1 has been filled out.  
Patient Number* Date of Study Drug Injection* **________/_________/________** *To be completed by the site.  
| Complete daily for 7 days or until the injection site has resolved (returned to normal) . Please bring back this completed diary to your next clinic visit. Day 7 Instructions Post Injection ____/____/_________ Day 8 Post Injection ____/____/_________ Day 9 Post Injection ____/____/_________ Day 10 Post Injection ____/____/_________ Day 11 Post Injection ____/____/________ Day 12 Post Injection ___/___/________ Day 13 Post Injection ____/____/_________ Check: Yes or No If yes, measure longest  diameter in cm Yes No Yes No Yes No  Yes No Yes No Yes No Yes No 1. Is there redness at  the injection site? ________cm ________cm ________cm ________cm ________cm ________cm ________cm Check: Yes or No Yes No Yes No Yes No Yes No Yes No Yes No Yes No 2. Is there firmness or  swelling at the  injection site? Check the pain  and/or itch box if  present Indicate if the pain  and/or itching is mild,  moderate or severe  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch  Pain  Itch 3. Have you  experienced any pain or itching at the  injection site? Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Mild Mild Mod Mod Severe Severe Yes No Yes No Yes No Yes No Yes No Yes No Yes No Name(s): Name(s): Name: Name: Name: Name: Name: 4. Have you taken or  applied any  medication for  injection site pain or  itching? Check: Yes or No Provide name of  medication(s) Grading Injection Site Pain or Itching   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
Grading Injection Site Pain **or Itching** Mild - Noticeable, does not interfere with activity Moderate - Interferes with activity, limiting activities of daily living Severe - Severely limiting self-care activities of daily living, incapacitating