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version history

| Version    | Date       |
|------------|------------|
| 07-12-2019 |            |
| l          | l1-08-2019 |
| 2          |            |
| 3          | 04-15-2020 |
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table of contents

| TABLE OF CONTENTS                                                      |    |
|------------------------------------------------------------------------|----|
| PROTOCOL SUMMARY .                                                     |    |
| STUDY SCHEMA                                                           |    |
| STUDY CALENDAR OF EVENTS .                                             |    |
| LIST OF ABBREVIATIONS.                                                 |    |
| 1 BACKGROUND AND RATIONALE                                             |    |
| 2 AIM AND ENDPOINTS                                                    |    |
| 2.1 P RIMARY A IM                                                      |    |
| 2 S ECONDARY A IMS .                                                   |    |
| 2.3 P RIMARY E NDPOINTS                                                |    |
| 2.4 S ECONDARY E NDPOINTS                                              |    |
| 3 STUDY DESIGN .                                                       |    |
| 3.1 G ENERAL D ESCRIPTION                                              |    |
| 3.2 D ESIGN OF C URRENT S TUDY .                                       |    |
| 4 OPERATIONAL CRITERIA .                                               |    |
| 4.1  SIRB REQUIREMENTS .                                               |    |
| 4.2  S UBJECT S TATUS                                                  |    |
| 4.3  PRESCREENING LOG                                                  |    |
| 4.4  CONSENT AND TRAINING                                              |    |
| 4.4.1 Nurse Teacher Education Program                                  |    |
| 4.2 Subject and Caregiver Consent                                      |    |
| 4.3 Study Diaries                                                      |    |
| 4.4  Ongoing Consent Process and Education .                           |    |
| 4.5 SCREENING PROCEDURES .                                             |    |
| 4.6 C ENTRAL E LIGIBILITY C ONFIRMATION  .                             |    |
| 4.7 E LIGIBILITY C RITERIA .                                           |    |
| 4.8 E NROLLMENT                                                        |    |
| 4.9 T REATMENT .                                                       |    |
| 4.10  DISCONTINUATION OF STUDY TREATMENT/INTERVENTION, WITHDRAWAL, AND |    |
| C COMPLIANCE                                                           |    |
| 4.11 FOLLOW-UP AND LOST TO FOLLOW-UP .                                 |    |
| 4.12 ACCRUAL SUSPENSION AND CLOSURE                                    |    |
| 4.13 E ND OF S TUDY D EFINITION                                        |    |
| 4.14 STUDY DISCONTINUATION AND CLOSURE                                 |    |
| 5 TREATMENT PLAN .                                                     |    |
| 5.1 DOSE MODIFICATION GUIDELINES                                       |    |
| 5.2  CONCOMITANT AND PROHIBITED MEDICATION                             |    |
| 5.3 D IETARY R ESTRICTIONS .                                           |    |
| 5.4  S UPPORTIVE C ARE G UIDELINES .                                   |    |
| 5.4.1 Antimicrobial Prophylaxis                                        |    |
| 5.4.2  Myeloid Growth Factors                                          |    |
| 5.4.3  Indications for Hospitalization .                               |    |
| 5.4.4  Transfusion Support                                             |    |
| 5.5  OVERDOSE                                                          |    |
| 5.6 CHANGES TO SITE OUTPATIENT MANAGEMENT CAPABILITIES .               |    |
| MCW Protocol No: IIT-Michaelis-OutpatientCPX-351                       | p4 |  
| 5.7  S UBJECT /C AREGIVER AND S ITE C OMMUNICATION P LAN .                                                                                  |
|---------------------------------------------------------------------------------------------------------------------------------------------|
| 5.8 D EFINITION OF A P ROTOCOL M ANDATED A P P O I N T M E N T .                                                                            |
| 5.9 D EFINITION OF A DMISSION , P ROVIDER R ECOMMENDATION AND I NPATIENT T IME ................... 34                                       |
| 5.9.1 Subject Refusal to be Admitted .                                                                                                      |
| 5.10 H EALTH - R ELATED Q UALITY OF L IFE Q UESTIONNAIRES                                                                                   |
| 6 REPORTING REQUIREMENTS                                                                                                                    |
| 6.1 D EFINITION OF AN A DVERSE E VENT  .                                                                                                    |
| 6.2 DEFINITION OF A SERIOUS ADVERSE EVENT (SAE)                                                                                             |
| 6.3  RELATIONSHIP OF AN ADVERSE EVENT TO STUDY ..........................................................................................37 |
| 6.4 E XPECTEDNESS OF AN A DVERSE E VENT                                                                                                     |
| 6.5 R OUTINE AND E XPEDITED R EPORTING .                                                                                                    |
| 6.6 S ERIOUS A DVERSE E VENT R EPORTING                                                                                                     |
| 6.7 A DVERSE E VENTS AND G RADE 4 A ES N OT M E TING S A E D E F I N I T I O N .                                                            |
| 6.8  U NANTICIPATED PROBLEM I NVOLVING R ISK TO S UBJECT OR O THER (UPIRSO) ........................ 41                                     |
| 6.9  R EPORTING P REGNANCY .                                                                                                                |
| 6.10  PROTOCOL DEVIATIONS AND OVERDOSE .                                                                                                    |
| 6.11 JAZZ PHARMACEUTICALS SAFETY LETTERS AND ACTION LETTERS                                                                                 |
| 6.12  CHANGES TO OUTPATIENT MANAGEMENT CAPABILITIES                                                                                         |
| 6.13 S UBJECT W ITHDRAWAL                                                                                                                   |
| 6.14  STAFF AND SUBJECT COMPLAINT REPORTING                                                                                                 |
| 6.15  REPORTING UPIRSO TO SUBJECTS .                                                                                                        |
| 6.16  E XTERNAL OR I NTERNAL A UDITING AT P ARTICIPATING S ITES                                                                             |
| 7  OPERATIONAL CONSIDERATIONS, MULTISITE ADMINISTRATION, SOURCE                                                                             |
| DOCUMENTS, AND DATA MANAGEMENT                                                                                                              |
| 7.1 SITE STAFF OPERATIONS.                                                                                                                  |
| 7.1.1 Staff Roles                                                                                                                           |
| 7.1.2 Training .                                                                                                                            |
| 7.1.3  Staff and Protocol Changes                                                                                                           |
| 7.1.4 Delegation of Authority Log                                                                                                           |
| 7.2 M ONITORING P LAN                                                                                                                       |
| 7.3  A UDIT P LAN                                                                                                                           |
| 7.4 A A UDIT AND M ONITORING R EPORT AND C ORRECTIVE A TION P LAN (CAP)  ................................. 48                               |
| 7.5 D EIDENTIFIED S OURCE D OCUMENTS , R EMOTE A C C ESS TO R ECORDS , AND S HADOW C HARTS                                                  |
| ..                                                                                                                                          |
| 7.6  T RANSFERRING S UBJECTS .                                                                                                              |
| 7.7  DATA LOCK AND VERIFICATION                                                                                                             |
| 7.8  CLOSEOUT PROCEDURES AND RETENTION OF STUDY DOCUMENTS                                                                                   |
| 7.9 STUDY RECORDS RETENTION  .                                                                                                              |
| 7.10  PUBLICATION AND DATA SHARING POLICY                                                                                                   |
| 7.11 E LECTRONIC D ATA C APTURE AND T IMELY D ATA E NTRY .                                                                                  |
| 8 REGULATORY COMPLIANCE, ETHICS AND MANAGEMENT .                                                                                            |
| 8.1 P RESTUDY R EQUIREMENTS FOR MCW                                                                                                         |
| 8.2  P ARTICIPATING S ITE A CTIVATION P ROCESS .                                                                                            |
| 8.2.1 Participating Site Selection Criteria                                                                                                 |
| 8.2.2  Participating Site Feasibility Assessment .                                                                                          |
| 8.2.3 Activation Letter                                                                                                                     |
| 8.3  R EGULATORY R EQUIREMENTS FOR MCW .                                                                                                    |
| 8.4  R EGULATORY R ESPONSIBILITIES FOR P ARTICIPATING S ITES .                                                                              |
| 8.5  SITE STANDARD OPERATING PROCEDURES (SOPS) .                                                                                            |
| MCW Protocol No: IIT-Michaelis-OutpatientCPX-351                                                                                            |  
  
Version No.: 3  
| 8.6 C ONTINUING P ROGRESS R EPORTS                                              |
|---------------------------------------------------------------------------------|
| 8.7  CAP, CLIA, AND REFERENCE RANGES .                                          |
| 8.8 S S CIENTIFIC R EVIEW C OMMITTEE .                                          |
| 8.9  DATA AND SAFETY MONITORING COMMITTEE                                       |
| 8.10  SUBJECT CONFIDENTIALITY AND ACCESS TO SOURCE DOCUMENTS/DATA               |
| 8.11 R ISK M ANAGEMENT                                                          |
| 8.11.1 Risk Assessment, Control and Review .                                    |
| 8.11.2  Safety Run-In Phase and Continuation Phase .                            |
| 8.11.3 Protection from Unnecessary Harm                                         |
| 8.12 CHANGES IN THE PROTOCOL, CONSENT OR OTHER TRIAL DOCUMENT  .                |
| 9 STATISTICAL CONSIDERATIONS                                                    |
| 9.1 A IMS                                                                       |
| 9.2 S AMPLE S IZE D ETERMINATION AND P OWER E STIMATE  .                        |
| 9.3 S UBJECT R EPLACEMENT                                                       |
| 9.4  S TOPPING R ULES                                                           |
| 9.5  I NTERIM A NALYSIS                                                         |
| 9.6  A NALYSIS M ETHOD .                                                        |
| 10 REFERENCES                                                                   |
| APPENDIX 1: PERFORMANCE STATUS CRITERIA                                         |
| APPENDIX 2: LOST TO FOLLOW-UP LETTER                                            |
| APPENDIX 3: PRESCREENING LOG .                                                  |
| APPENDIX 4: NURSE TEACHER EDUCATION PROGRAM VALIDATION GUIDE ............... 69 |
| APPENDIX 5: STUDY DIARY                                                         |
| APPENDIX 6: PATIENT-REPORTED OUTCOME MEASURES                                   |  
  
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protocol summary

| PROTOCOL SUMMARY                                                           |                                                                   |
|----------------------------------------------------------------------------|-------------------------------------------------------------------|
| A multi-institutional, phase IV project to study the feasibility of safely |                                                                   |
| managing patients receiving induction with liposomal daunorubicin          |                                                                   |
| Title                                                                      | and cytarabine (CPX-351) for acute myeloid leukemia (AML) in an   |
| outpatient environment                                                     |                                                                   |
| Sponsor                                                                    | Laura C. Michaelis, MD (Medical College of Wisconsin)             |
| Principal                                                                  | Laura C. Michaelis, MD                                            |
| Investigator                                                               |                                                                   |
| Clinical Trial Phase                                                       | Phase IV                                                          |
| Adults with newly diagnosed therapy-related acute myeloid leukemia         |                                                                   |
| Study Population                                                           | (t-AML) or AML with myelodysplasia-related changes (AML-MRC)      |
| To estimate the feasibility of an outpatient care model for induction      |                                                                   |
| Primary Aim                                                                | and management of patients with AML who receive induction therapy |
| with liposomal daunorubicin and cytarabine (CPX-351).                      |                                                                   |
| 1. To estimate the overall inpatient time for subjects who receive         |                                                                   |
| CPX-351 induction as an outpatient.                                        |                                                                   |
| 2. To estimate the incidence of admission to an intensive care unit in     |                                                                   |
| subjects treated in an outpatient environment.                             |                                                                   |
| 3. To estimate the incidence of 30-day all-cause mortality in subjects     |                                                                   |
| treated in an outpatient model                                             |                                                                   |
| 4. To estimate the incidence of 60-day all-cause mortality in subjects     |                                                                   |
| treated in an outpatient model.                                            |                                                                   |
| 5. To describe the health care resource utilization for subjects           |                                                                   |
| Secondary Aims                                                             | induced with an outpatient care model.                            |
| 6. To assess the health-related quality of life, anxiety levels and        |                                                                   |
| treatment-related worry for subjects receiving induction                   |                                                                   |
| chemotherapy in an outpatient environment immediately prior to             |                                                                   |
| induction, 7–10 days following induction and 30 and 60 days after          |                                                                   |
| induction.                                                                 |                                                                   |
| 7. To assess the health-related quality of life anxiety levels and         |                                                                   |
| treatment-related worry for the primary caregiver of subjects              |                                                                   |
| receiving induction chemotherapy in an outpatient environment              |                                                                   |
| immediately prior to induction, 7–10 days following induction and          |                                                                   |
| 30 and 60 days after induction.                                            |                                                                   |  
| Single-arm, multicenter run-in phase (six subjects), multicenter       |                                                                   |
|------------------------------------------------------------------------|-------------------------------------------------------------------|
| Study Design                                                           | continuation phase (114 subjects), Phase IV study.                |
| CPX-351 is administered, according to FDA approval, to subjects who    |                                                                   |
| meet medical and logistical criteria for study enrollment. The study   |                                                                   |
| intervention is the application of a prescribed outpatient care model, |                                                                   |
| Intervention                                                           | including a nurse teacher educational program and quality of life |
| Description                                                            | surveys for both subjects and caregivers. Induction therapy and   |
| medical follow up are performed without prophylactic admission to an   |                                                                   |
| inpatient facility.                                                    |                                                                   |
| Number of Subjects                                                     | 120 subjects (6 for run-in phase, 114 for continuation phase)     |
| Subject                                                                |                                                                   |
| Participation                                                          | 60 days                                                           |
| Duration                                                               |                                                                   |
| Estimated Time to                                                      |                                                                   |
| Complete                                                               | 2 months                                                          |
| Enrollment:                                                            |                                                                   |  
  
  
u-In Phase: Six subjects, enrolled according to monitoring/stopping rules (refer to section 9.4).
ontinuation Phase: After DSMC safety assessment of the run-in phase, the DSM
TUDY SCHEMA  
  
Both subject and caregiver undergo the consent process. Each site implements a study-specific Nurse Teacher Education Program for all
insenting subjects and caregivers. Qual Prespecified pattern of monitoring applied (refer to Study Calendar of Events). Subjects are admitted/readmitted according to section ICW Protocol No: IIT-Michaelis-OutpatientCPX-351
Tersion No.: 3 ersion Date: 04/15/2020  
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| "I have reviewed all inclusion/exclusion criteria and confirm the subject is eligible."   |      |
|-------------------------------------------------------------------------------------------|------|
| Enrolling Investigator Name (print)                                                       |      |
| Enrolling Investigator Signature                                                          | Date |  
| "This subject is eligible for the study and considered on study/enrolled."   |      |
|------------------------------------------------------------------------------|------|
| MCW Study PI Name (printed)                                                  |      |
| *or MCW Designee                                                             |      |
| MCW Study PI Signature                                                       | Date |
| *or MCW Designee                                                             |      |
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" !

"-122--**-5!.&22&0
,D=9K=MK=L@=>GJEGFL@=F=PLH9?=
Date: Dear
__
The research study team has been unable to contact you regarding the clinical trial in which you participate. We would like to discuss how you are doing and if we may continue contacting you.  
Please contact us at j Sincerely,  
| Which specific eligibility criteria was not
ell on the met?                                                                        | e.g., inclusion criteria 3      |                                            |
|------------------------------------------------------------------------|---------------------------------|--------------------------------------------|
| Participating site PI signature/date (at study closure):               |                                 |                                            |
| Refer to sIRB of record policies regarding prescreening and screening. | Reason subject refused consent? | treatment options (specify), cost, lost to |
| Consented?                                                             | /es/No                          |                                            |
| APPENDIX 3: Prescreening Log                                           |                                 | Yes/No                                     |
| Site:                                                                  | Date of
contact                                 | deidentified)                              |
| Subject
| | |
" !

| Study:                                                                 |                                 |                                            |  
7ersion Date: 04/15/2020 MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3
| | |
appendix 4 nurse teacher education

After completing the standardized education with the subject and caregiver, review the following key points to assure information has been understood and the outpatient management plan will be followed in a safe manner.  
1.  
Validate that subject/caregiver has the following items at home or can verbalize plans to obtain prior to treatment start date.  
2.  
Thermometer a.  
Reliable telephone(s)
b.  
i.   Charging accessories for mobile devices Reliable transportation c.  
Ask the subject to teach-back about each of the following topics at a minimum. Assure the key points are addressed. Reinforce education if there are missed items.  
Temperature monitoring a.  
Take temperature two times per day 1.  
i.   Call if temperature is 100.4°F or greater b.   Infection prevention i.   Hand hygiene c. Pregnancy prevention i.   Effective birth control method for subject's gender How to contact the doctor and/or clinic d.  
e.    Caregiver accountabilities Availability 1.  
1.  
Transportation 111. Assistance f.  
Subject accountabilities Timely communication of new or concerning symptoms 1.  
11.  
Attend appointments Take medications 11.  
Answer clinic phone calls iv.  
v.   Follow doctor recommendations Provide subject and caregiver with handout slides reinforcing key points.
| | |
subject and caregiver id

"I verify that the subject and caregiver have completed and adequately understand the study-dictated nurse teacher educational program. I verify the subject and caregiver have capacity to comply with outpatient management program".
appendix 5 study diary
subject instructions

Please bring this study diary to all scheduled hospital visits.  
Make sure to call or page your care team for any other new or concerning symptoms. You may also record them on the study diary, but do not hesitate to call for anything of concern. Especially for symptoms like pain, nausea, vomiting, rash, oral or dental problems, intestinal problems like diarrhea or constipation, or any other concern for you or your caregiver.
appendix 5 study diary
if your temperature is 100.4

.  
Call or page your physician right away. Use the contact information provided during your educational session.  
.  
Follow that physician's instructions regarding next steps.  
.  
Have your caregiver bring you to the hospital right away. If that caregiver is not available, please either call 911 to have an ambulance attend to you OR ask your physician if you are safe to drive yourself.
appendix 5 study diary
emergency information for other hospitals

This subject is on a clinical trial examining the safety of outpatient CPX-351 AML treatment.  
Please contact the site investigator if the subject presents to your hospital.  
| PAGE 2 of 8                       |                          |                             |        |        |        |        |        |        |        |        |        |        |        |        |
|-----------------------------------|--------------------------|-----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Any new or worsening side effects or
symptoms? Describe                                   | Version Date: 04/15/2020 |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| Antiviral                         | Yes No                   | Yes No                      | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No |        |
| Yes No                            | Yes                      |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                 | No                       | Yes No                      | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                               | Yes                      | Yes                         | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                               | Yes                      | Yes                         | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifung al                       | Yes No                   | Yes No                      | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | Yes No |
| Yes                               | Yes                      | Yes                         | Yes    |        |        |        |        |        |        |        |        |        |        |        |
| Yes                               | Yes                      | Yes                         | MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                       |                          |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): | Time                     | Subject signature and date: |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                              |                          |                             |        |        |        |        |        |        |        |        |        |        |        |        |  
Study Diary Study Diary  
| Any new or worsening side effects or
symptoms? Describe                                     | PAGE 3 of 8   | Version Date: 04/15/2020   |        |        |        |        |        |        |        |        |        |        |        |        |
|-------------------------------------|---------------|----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Antiviral                           | Yes No        | Yes No                     | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No |        |        |
| Yes No                              | Yes No        |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| Yes                                 |               |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                   | No            | Yes No                     | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                                 | Yes           | Yes                        | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                                 | Yes           | Yes                        | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifungal                          | Yes No        | Yes No                     | No     | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | No     | Yes No | Yes No | Yes No |
| Yes                                 | Yes           | Yes                        | Subject signature and date:
MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                         |               |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): _ | Time          |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                                |               |                            |        |        |        |        |        |        |        |        |        |        |        |        | | Any new or worsening side effects or
symptoms? Describe                                     | PAGE 4 of 8   | Version Date: 04/15/2020   |        |        |        |        |        |        |        |        |        |        |        |        |
|-------------------------------------|---------------|----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Antiviral                           | Yes No        | Yes No                     | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No |        |        |
| Yes No                              | Yes No        |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| Yes                                 |               |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                   | No            | Yes No                     | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                                 | Yes           | Yes                        | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                                 | Yes           | Yes                        | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifungal                          | Yes No        | Yes No                     | No     | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | No     | Yes No | Yes No | Yes No |
| Yes                                 | Yes           | Yes                        | Subject signature and date:
MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                         |               |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): _ | Time          |                            |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                                |               |                            |        |        |        |        |        |        |        |        |        |        |        |        |  
Study Diary Study Diary  
| Any new or worsening side effects or
symptoms? Describe                                   | PAGE 5 of 8   | Version Date: 04/15/2020    |        |        |        |        |        |        |        |        |        |        |        |        |
|-----------------------------------|---------------|-----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Antiviral                         | Yes No        | Yes No                      | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No |        |
| Yes No                            | Yes           |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                 | No            | Yes No                      | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                               | Yes           | Yes                         | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifung al                       | Yes No        | Yes No                      | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | Yes No |
| Yes                               | Yes           | Yes                         | Yes    |        |        |        |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                       |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): | Time          | Subject signature and date: |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                              |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |  
Study Diary  
| Any new or worsening side effects or
symptoms? Describe                                   | PAGE 6 of 8   | Version Date: 04/15/2020    |        |        |        |        |        |        |        |        |        |        |        |        |
|-----------------------------------|---------------|-----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Antiviral                         | Yes No        | Yes No                      | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No |        |
| Yes No                            | Yes           |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                 | No            | Yes No                      | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                               | Yes           | Yes                         | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifung al                       | Yes No        | Yes No                      | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | Yes No |
| Yes                               | Yes           | Yes                         | Yes    |        |        |        |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                       |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): | Time          | Subject signature and date: |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                              |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |  
Study Diary  
| Any new or worsening side effects or
symptoms? Describe                                   | PAGE 7 of 8   | Version Date: 04/15/2020    |        |        |        |        |        |        |        |        |        |        |        |        |
|-----------------------------------|---------------|-----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Antiviral                         | Yes No        | Yes No                      | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | No     | Yes No | Yes No | Yes No |        |
| Yes No                            | Yes           | Yes                         |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                 | No            | Yes No                      | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                               | Yes           | Yes                         | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifung al                       | Yes No        | Yes No                      | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | Yes No |
| Yes                               | Yes           | Yes                         | Yes    |        |        |        |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                       |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): | Time          | Subject signature and date: |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                              |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |  
| Any new or worsening side effects or
symptoms? Describe                                   | PAGE 8 of 8   | Version Date: 04/15/2020    |        |        |        |        |        |        |        |        |        |        |        |        |
|-----------------------------------|---------------|-----------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Antiviral                         | Yes No        | Yes No                      | Yes No | Yes No | Yes No | Yes No | No     | Yes No | Yes No | Yes No | Yes No | Yes No | Yes No |        |
| Yes No                            | Yes           |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| Medication Taken?                 | No            | Yes No                      | No     | No     | No     | No     | No     | No     | No     | No     | No     | No     | Yes No | No     |
| Yes                               | Yes           | Yes                         | Yes    | Yes    | Yes    | Yes    |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | Yes    | Yes    |        |        |        |        |        |        |        |        |        |        |
| Antifung al                       | Yes No        | Yes No                      | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | No     | No     | Yes No | Yes No |
| Yes                               | Yes           | Yes                         | Yes    |        |        |        |        |        |        |        |        |        |        |        |
| Yes                               | Yes           | Yes                         | MCW Protocol No: IIT-Michaelis-OutpatientCPX-351
Version No.: 3        |        |        |        |        |        |        |        |        |        |        |        |
| Temperature                       |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |
| ubject # (completed by hospital): | Time          | Subject signature and date: |        |        |        |        |        |        |        |        |        |        |        |        |
| Date                              |               |                             |        |        |        |        |        |        |        |        |        |        |        |        |  
Study Diary
appendix 6 patient-reported outcome measures
emergency information for other hospitals

Please respond to each question by marking one box per row.  
In the past 7 days…  
| Never                                   | Rarely                                   | Sometimes   | Often   | Always   |      |    |
|-----------------------------------------|------------------------------------------|-------------|---------|----------|------|----|
| →                                       | →                                        | →           | →       | →        |      |    |
| FATEXP20                                | How often did you feel tired?........... | 1           | 2       | 3        | 4    | S  |
| How often did you experience extreme    | →                                        | .           | .       | →        | s 🙂 |    |
| FATEXP5                                 | exhaustion?.                             | 3           |         |          |      |    |
| How often did you run out of            | →                                        | 2           | □       | →        | s 🙂 |    |
| energy?.                                |                                          |             |         |          |      |    |
| How often did your fatigue limit you at | →                                        | →           | →       | →        | →    |    |
| i                                       | 3                                        | S           |         |          |      |    |
| work (include work at home)?            |                                          |             |         |          |      |    |
| How often were you too tired to think   | →                                        | →           | →       | →        | →    |    |
| i                                       | 2                                        | 3           | 4       | S        |      |    |
| clearly?                                |                                          |             |         |          |      |    |
| How often were you too tired to take a  | →                                        | →           | →       | □        | →    |    |
| bath or shower?.                        | l                                        | 2           | 3       | 4        | S    |    |
| How often did you have enough energy    | →                                        | →           | →       | →        | →    |    |
| S                                       | 4                                        | 3           | 12      |          |      |    |
| to exercise strenuously?                |                                          |             |         |          |      |    |  
2 May 2016
© 2008-2016 PROMIS Health Organization and PROMIS Cooperative Group Page 1 of 1 Version No.: 3
emotional distress-anxiety - short form
emergency information for other hospitals

Please respond to each question or statement by marking one box per row.
emotional distress-anxiety - short form
in the past 7 days...

| In the past 7 days…                        | Rarely   | Sometimes   | Otten   | Always   |    |
|--------------------------------------------|----------|-------------|---------|----------|----|
| Never                                      |          |             |         |          |    |
| EDANX01                                    | □        | →           | □       | →        | □  |
| I felt fearful                             | 1        | 2           | 3       | 4        | S  |
| I found it hard to focus on anything other |          |             |         |          |    |
| EDANX40                                    | □        | →           | □       | →        | →  |
| than my anxiety                            | l        | 2           | 3       | 4        | S  |
| EDANX41                                    | 😂       | □           | □       | →        | □  |
| My worries overwhelmed me.                 | 2        |             |         |          |    |
| l                                          | 3        | 4           | S       |          |    |
| EDANX53                                    | →        | □           |         |          |    |
| I felt uneasy                              | →        | →           | →       |          |    |
| l                                          | 2        | 3           | 4       | S        |    |
emotional distress-depression - short form
in the past 7 days...

Please respond to each question or statement by marking one box per row.  
| In the past 7 days...   | Never              | Rarely   | Sometimes   | Often   | Always   |    |
|-------------------------|--------------------|----------|-------------|---------|----------|----|
| →                       | →                  | →        | →           | →       |          |    |
| EDDEP04                 | I felt worthless . | l        | 2           | 3       | S        |    |
| 4                       |                    |          |             |         |          |    |
| →                       | →                  | →        | →           | →       |          |    |
| EDDEP06                 | I felt helpless    | 1        | 2           | 3       | 4        | S  |
| □                       | □                  | □        | □           | □       |          |    |
| EDDEP29                 | I felt depressed . | l        | 2           | 3       | 4        | 5  |
| □                       | □                  | □        | □           | □       |          |    |
| EDDEP41                 | I felt hopeless    | 1        | 2           | 3       | 4        | S  |
physical function - short form
in the past 7 days...

Please respond to each question or statement by marking one box per row.  
| Without                                      | With a                                     | With       | With        |           |    |    |
|----------------------------------------------|--------------------------------------------|------------|-------------|-----------|----|----|
| little                                       | Unable                                     |            |             |           |    |    |
| any                                          | some                                       | much       |             |           |    |    |
| difficulty                                   | difficulty                                 | difficulty | difficulty  | to do     |    |    |
| Are you able to do chores such as            |                                            |            |             |           |    |    |
| PFA11                                        | 😂                                         | 😀         | 😀          | →         | 😀 |    |
| vacuuming or yard work?.                     | s                                          | 4          | 3           | 2         |    |    |
| PFA21                                        | Are you able to go up and down stairs at a | -          | -           | □         | -  | -  |
| normal pace? .                               | 5                                          | 4          | 3           | 2         | i  |    |
| Are you able to go for a walk of at least 15 |                                            |            |             |           |    |    |
| PFA23                                        | →                                          | 😀         | 😀          | →         | 😀 |    |
| minutes? .                                   | S                                          | 4          | 3           | 2         | 1  |    |
| PFA53                                        | Are you able to run errands and shop? …….  | →          | →           | →         | →  | →  |
| 5                                            | 4                                          | 3          | 2           | 1         |    |    |
| Not at all                                   | Very little                                | Somewhat   | Quite a lot | Cannot do |    |    |
| Does your health now limit you in doing two  |                                            |            |             |           |    |    |
| PC12                                         | □                                          | 😀         | 😀          | □         | □  |    |
| hours of physical labor? .                   | S                                          | 4          | 3           | 2         | i  |    |
| Does your health now limit you in doing      |                                            |            |             |           |    |    |
| moderate work around the house like          |                                            |            |             |           |    |    |
| PB1                                          | □                                          | □          | □           | 😀        | □  |    |
| vacuuming, sweeping floors or carrying in    | S                                          | 4          | 3           | 2         | i  |    |
| groceries? .                                 |                                            |            |             |           |    |    |
| Does your health now limit you in lifting or |                                            |            |             |           |    |    |
| PFA5                                         | →                                          | →          | →           | →         | →  |    |
| carrying groceries?.                         | S                                          | 4          | 3           | 2         | 1  |    |
| Does your health now limit you in doing      |                                            |            |             |           |    |    |
| heavy work around the house like             |                                            |            |             |           |    |    |
| PFA4                                         | →                                          | →          | →           | →         | □  |    |
| scrubbing floors, or lifting or moving       | S                                          | 4          | 3           | 2         | l  |    |
| heavy furniture?                             |                                            |            |             |           |    |    |
sleep disturbance - short form
in the past 7 days...

Please respond to each question or statement by marking one box per row.
sleep disturbance - short form
in the past 7 days...

| Very poor              | Poor                            | Fair         | Good     | Very good   |           |    |
|------------------------|---------------------------------|--------------|----------|-------------|-----------|----|
| My sleep quality was . | →                               | →            | →        | →           | →         |    |
| p109                   | s                               | 4            | 3        | 2           | l         |    |
| In the past 7 days...  | Not at all                      | A little bit | Somewhat | Quite a bit | Very much |    |
| Seep 116               | My sleep was refreshing. .      | →            | →        | →           | -         | →  |
| s                      | 4                               | 3            | 2        | 1           |           |    |
| →                      | →                               | →            | □        | →           |           |    |
| Sleep20                | I had a problem with my sleep.  | 2            | 3        | 4           | s         |    |
| l                      |                                 |              |          |             |           |    |
| nn                     | I had difficulty falling asleep | →            | →        | →           | →         | →  |
| l                      | 2                               | 3            | 4        | S           |           |    |  
2 June 2016
© 2008-2016 PROMIS Health Organization and PROMIS Cooperative Group
ability to participate in social
please respond to each item

| Sometimes                              | Usually                                    | Always   |    |    |    |    |
|----------------------------------------|--------------------------------------------|----------|----|----|----|----|
| Never                                  | Rarely                                     |          |    |    |    |    |
| I have trouble doing all of my regular |                                            |          |    |    |    |    |
| SRPPER11                               | □                                          | □        | □  | □  | □  |    |
| CaPS                                   | leisure activities with others .           | S        | 4  | 3  | 2  | l  |
| I have trouble doing all of the family |                                            |          |    |    |    |    |
| BRPPER18                               | 😂                                         | 😂       | 😂 | 😂 | 😂 |    |
| CaPS                                   | activities that I want to do               | S        | 4  | 3  | 2  | i  |
| BRPPER23                               | I have trouble doing all of my usual work  | □        |    |    |    |    |
| □                                      | 😂                                         | □        | □  |    |    |    |
| CaPS                                   | (include work at home) .                   | S        | 4  | 3  | 2  | 1  |
| BRPPER46                               | I have trouble doing all of the activities | □        | →  | □  | □  | →  |
| CaPS                                   | with friends that I want to do .           | s        | 4  | 3  | 2  | l  |
| ..                                     |                                            |          |    |    |    |    |
instrumental support - short form
please respond to each item

| Never                                  | Rarely                        | Sometimes   | Usually   | Always   |    |    |
|----------------------------------------|-------------------------------|-------------|-----------|----------|----|----|
| Do you have someone to help you if you | □                             | □           | □         | □        | □  |    |
| CC31052                                | are confined to bed? .        | 1           | 2         | 3        | 4  | S  |
| Do you have someone to take you to the | □                             | 😂          | 😂        | □        | →  |    |
| CC31055                                | doctor if you need it? .      | i           | 2         | 3        | 4  | S  |
| Do you have someone to help with your  | □                             | □           | □         | □        | □  |    |
| CC31065                                | daily chores if you are sick? | i           | 2         | 3        | 4  | S  |
| Do you have someone to run errands if  | □                             | □           | □         | □        | □  |    |
| SSS                                    | you need it? .                | l           | 2         | 3        | 4  | S  |
emotional support - short form
please respond to each item

| Never                                   | Rarely                      | Sometimes   | Usually   | Always   |    |    |
|-----------------------------------------|-----------------------------|-------------|-----------|----------|----|----|
| I have someone who will listen to me    | □                           | □           | □         | □        | →  |    |
| FSE31053x2                              | when I need to talk.        | 1           | 2         | 3        | 4  | S  |
| I have someone to confide in or talk to | □                           | □           | □         | □        | □  |    |
| FSE31059                                | about myself or my problems | 1           | 2         | 3        | 4  | 5  |
| I have someone who makes me feel        | →                           |             |           |          |    |    |
| SS12x                                   | 😂                          | 😂          | 😂        | 😂       |    |    |
| appreciated                             | i                           | 2           | 3         | 4        | S  |    |
| I have someone to talk with when I have | □                           | □           | 😂        | □        | □  |    |
| SQ3x2                                   | a bad day                   | l           | 2         | 3        | 4  | S  |
emotional support - short form
nci pro-ctcae™️ items item library

As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an 😉
in the one box that best describes your experiences over the past 7 days...  
1.  
In the last 7 days, what was the SEVERITY of your MOUTH OR THROAT SORES at their  
| WORST?           |                |
|------------------|----------------|
| O None           | O Mild         |
| dily activities? |                |
| O Not at all     | O A little bit |  
| O Moderate   |
|--------------|
| O Somewhat   |  
| - Severe      |
|---------------|
| O Quite a bit |  
| O Very severe   |
|-----------------|
| O Very much     |  
In the last 7 days, how much did MOUTH OR THROAT SORES INTERFERE with your usual or  
  
- Rarely  
  
  
  
| - Frequently   |
|----------------|
| O Severe       |  
| O Almost con-   |
|-----------------|
| stantly         |
| O Very severe   |  
In the last 7 days, what was the SEVERITY of your NAUSEA at its WORST?  
  
In the last 7 days, how OFTEN did you have VOMITING?  
In the last 7 days, what was the SEVERITY of your VOMITING at its WORST?  
  
  
O Almost constantly O Very severe In the last 7 days, how OFTEN did you have LOOSE OR WATERY STOOLS  
  
(DIARRHEA/DIARRHOEA)?  
  
  
  
  
  
5.  
  
In the last 7 days, did you have any RASH?  
  
  
The PRO-CTCAE !" items and information herein were developed by the NATIONAL CANCER INSTITUTE at the NATIONAL
INSTITUTES OF HEALTH, in Bethesda, Maryland, U.S.A.  Use of the PRO-CTCAE'" is subject to NCI's Terms of Use.  
MCW Protocol No: IIT-Michaelis-OutpatientCPX-351 In the last 7 days, how OFTEN did you have NAUSEA?
emotional support - short form
nci pro-ctcae™️ items item library

In the last 7 days, what was the SEVERITY of your NUMBNESS OR TINGLING IN YOUR
7.  
HANDS OR FEET at its WORST?  
O None O Mild O Moderate O Severe In the last 7 days, how much did NUMBNESS OR TINGLING IN YOUR HANDS OR FEET INTERFERE with your usual or daily activities?  
O Not at all O A little bit O Somewhat O Quite a bit O Very severe Q Very much 8.  
In the last 7 days, what was the SEVERITY of your BLURRY VISION at its WORST?  
- Very severe  
| In the last 7 days, what was the SEVERITY of your BLURRY VISION at its WORST?     |                |            |               |               |
|-----------------------------------------------------------------------------------|----------------|------------|---------------|---------------|
| O None                                                                            | O Mild         | O Moderate | O Severe      | - Very severe |
| In the last 7 days, how much did BLURRY VISION INTERFERE with your usual or daily |                |            |               |               |
| activities?                                                                       |                |            |               |               |
| O Not at all                                                                      | O A little bit | O Somewhat | O Quite a bit | O Very much   |  
O Very much Do you have any other symptoms that you wish to report?  
| O Yes                                                            | o No                                                             |            |          |        |
|------------------------------------------------------------------|------------------------------------------------------------------|------------|----------|--------|
| Please list any other symptoms:                                  |                                                                  |            |          |        |
| In the last 7 days, what was the SEVERITY of this symptom at its |                                                                  |            |          |        |
| 1.                                                               | WORST?                                                           |            |          |        |
| - None                                                           | O Mild                                                           | O Moderate | O Severe | 0 Very |
| severe                                                           |                                                                  |            |          |        |
| 2.                                                               | In the last 7 days, what was the SEVERITY of this symptom at its |            |          |        |
| WORST?                                                           |                                                                  |            |          |        |
| - None                                                           | O Mild                                                           | O Moderate | O Severe | O Very |
| severe                                                           |                                                                  |            |          |        |
| 3.                                                               | In the last 7 days, what was the SEVERITY of this symptom at its |            |          |        |
| WORST?                                                           |                                                                  |            |          |        |
| - None                                                           | ✪ Mild                                                           | O Moderate | O Severe | O Very |
| severe                                                           |                                                                  |            |          |        |
| 4.                                                               | In the last 7 days, what was the SEVERITY of this symptom at its |            |          |        |
| WORST?                                                           |                                                                  |            |          |        |
| - None                                                           | O Mild                                                           | O Moderate | O Severe | - Very |
| severe                                                           |                                                                  |            |          |        |
| 5.                                                               | In the last 7 days, what was the SEVERITY of this symptom at its |            |          |        |
| WORST?                                                           | O Severe                                                         |            |          |        |
| O None                                                           | O Mild                                                           | O Moderate | O Very   |        |
| severe                                                           |                                                                  |            |          |        |  
The PRO-CTCAE''' items and information herein were developed by the NATIONAL CANCER INSTITUTE at the NATIONAL
INSTITUTES OF HEALTH, in Bethesda, Maryland, U.S.A.  Use o
nci pro-ctcae™️ items
nci pro-ctcae™️ items item library

Item Library Version 1.0 English Form created on 5 September 2018 The PRO-CTCAE''' items and information herein were developed by the NATIONAL CANCER INSTITUTE at the NATIONAL
INSTITUTES OF HEALTH, in Bethesda, Maryland, U.S.A.  Use MCW Protocol No: IIT-Michaelis-OutpatientCPX-351 Version No.: 3
outpatient treatment worries and burden
nci pro-ctcae™️ items item library

We are interested in understanding how people feel about getting intensive induction chemotherapy for leukemia as an outpatient, meaning that they come in regularly to the clinic to receive therapy instead of staying in the hospital.  
1. How worried are you about getting intensive induction chemotherapy as an outpatient?  
2. How worried are you about having medical complications at home? 3. If you have complications at home, how worried are you about being able to quickly reach your doctors by phone?  
4.  If you have complications at home, how worried are you about being able to quickly reach your nurses by phone?  
5. How worried are you about being a burden to your loved one or caregiver?  
1 = not at all worried 2 = a little worried 3 = somewhat worried 4 = quite worried 5 = very worried 6. How confident are you that your loved one or caregiver is able to take care of you at home?  
7. How confident are you that your loved one or caregiver can manage your daily medical needs?  
8.  How confident are you that your loved one or caregiver can manage any cmplications?  
1 = not at all confident 2 = a little confident 3 = somewhat confident 4 = quite confident 5 = very confident At 30 days, only:
9. Please describe any additional worries that you have experienced during the last 30 days.  
[Textbox]
outpatient treatment worries of caregivers
nci pro-ctcae™️ items item library

1. How worried are you about being the primary caregiver for your loved at home?  
2. How worried are you about your loved one having medical complications at home?  
3. How worried are you about being able to quickly reach your loved one's doctors by phone?  
4. How worried are you about being able to quickly reach your loved one's nurses by phone?  
5. How worried are you about feeling that your loved one is a burden?  
1 = not at all worried 2 = a little worried 3 = somewhat worried 4 = quite worried 5 = very worried 6. How confident are you that you are able to take care of your loved one at home?  
7. How confident are you that you are able to manage daily medical needs for your loved one at home?  
8. How confident are you that you can manage any complications of your loved one's therapy? 9. How confident are you that you can provide self-care while taking care of your loved one?  
1 = not at all confident 2 = a little confident 3 = somewhat confident 4 = quite confident 5 = very confident At 30 days, only: 10. Please describe any additional worries that you have experienced during the last 30 days. [Textbox]
demographics
nci pro-ctcae™️ items item library

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