untitled h1
methods for evaluation of measurable

All measurements should be taken and recorded in metric notation using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the treatment.  
The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up. Imaging-based evaluation is preferred to evaluation by clinical examination unless the lesion(s) being followed cannot be imaged but are assessable by clinical exam. Clinical lesions Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes) and 10 mm diameter as assessed using calipers (e.g., skin nodules). In the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended.  
Chest x-ray Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable. Conventional CT and MRI This guideline has defined measurability of lesions on CT scan based on the assumption that CT slice thickness is 5 mm or less. If CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. MRI is also acceptable in certain situations (e.g. for body scans). Use of MRI remains a complex issue. MRI has excellent contrast, spatial, and temporal resolution; however, there are many image acquisition variables involved in MRI, which greatly impact image quality, lesion conspicuity, and measurement. Furthermore, the availability of MRI is variable globally. As with CT, if an MRI is performed, the technical specifications of the scanning sequences used should be optimized for the evaluation of the type and site of disease. Furthermore, as with CT, the modality used at follow-up should be the same as was used at baseline and the lesions should be measured/assessed on the same pulse sequence. It is beyond the scope of the RECIST guidelines to prescribe specific MRI pulse sequence parameters for all scanners, body parts, and diseases. Ideally, the same type of scanner should be used and the image acquisition protocol should be followed as closely as possible to prior scans. Body scans should be performed with breath-hold scanning techniques, if possible. PET-CT At present, the low dose or attenuation correction CT portion of a combined PET-CT is not always of optimal diagnostic CT quality for use with RECIST measurements. However, if the site can document that the CT performed as part of a PET-CT is of identical diagnostic quality to a diagnostic CT
(with IV and oral contrast), then the CT portion of the PET-CT can be used for RECIST measurements and can be used interchangeably with conventional CT in accurately measuring cancer lesions over time. Note, however, that the PET portion of the CT introduces additional data which may bias an investigator if it is not routinely or serially performed. Ultrasound Ultrasound is not useful in assessment of lesion size and should not be used as a method of measurement. Ultrasound examinations cannot be reproduced in their entirety for independent review at a later date and, because they are operator dependent, it cannot be guaranteed that the same technique and measurements will be taken from one assessment to the next. If new lesions are identified by ultrasound in the course of the study, confirmation by CT or MRI is advised. If there is concern about radiation exposure at CT, MRI may be used instead of CT in selected instances. Endoscopy, Laparoscopy The utilization of these techniques for objective tumor evaluation is not advised. However, such techniques may be useful to confirm complete pathological response when biopsies are obtained or to determine relapse in trials where recurrence following complete response
(CR) or surgical resection is an endpoint.  
Tumor markers Tumor markers alone cannot be used to assess response. If markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response. Specific guidelines for both CA-125 response (in recurrent ovarian cancer) and PSA response (in recurrent prostate cancer) have been published [*JNCI* 96:487-488, 2004; *J Clin Oncol* 17, 3461-3467, 1999; *J Clin Oncol* 26:1148-1159, 2008]. In addition, the Gynecologic Cancer Intergroup has developed CA-125 progression criteria which are to be integrated with objective tumor assessment for use in firstline trials in ovarian cancer [*JNCI* 92:1534-1535, 2000].  
Cytology, Histology These techniques can be used to differentiate between partial responses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in tumor types, such as germ cell tumors, where known residual benign tumors can remain).  
The cytological confirmation of the neoplastic origin of any effusion that appears or worsens during treatment when the measurable tumor has met criteria for response or stable disease is mandatory to differentiate between response or stable disease (an effusion may be a side effect of the treatment) and progressive disease.  
FDG-PET While FDG-PET response assessments need additional study, it is sometimes reasonable to incorporate the use of FDG-PET scanning to complement CT scanning in assessment of progression
(particularly possible 'new' disease). New lesions on the basis of FDG-PET imaging can be identified according to the following algorithm:
a.Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of PD based on a new lesion.  
b.No FDG-PET at baseline and a positive FDG-PET at follow-up: If the positive FDG-PET at followup corresponds to a new site of disease confirmed by CT, this is PD. If the positive FDG-PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up CT scans are needed to determine if there is truly progression occurring at that site (if so, the date of PD will be the date of the initial abnormal FDG-PET scan). If the positive FDG-PET at follow-up  
corresponds to a pre-existing site of disease on CT that is not progressing on the basis of the anatomic images, this is not PD.  
c. FDG-PET may be used to upgrade a response to a CR in a manner similar to a biopsy in cases where a residual radiographic abnormality is thought to represent fibrosis or scarring. The use of FDG-PET in this circumstance should be prospectively described in the protocol and supported by disease-specific medical literature for the indication. However, it must be acknowledged that both approaches may lead to false positive CR due to limitations of FDG-PET and biopsy resolution/sensitivity.
Note: A 'positive' FDG-PET scan lesion means one which is FDG avid with an uptake greater than twice that of the surrounding tissue on the attenuation corrected image.
untitled h1
response criteria evaluation of target

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.  
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
untitled h1
evaluation of non-target lesions

Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis)
Note: If tumor markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response.  
Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits Progressive Disease (PD): Appearance of one or more new lesions and/or *unequivocal progression* of existing non-target lesions. *Unequivocal progression* should not normally trump target lesion status.  
It must be representative of overall disease status change, not a single lesion increase.  
Although a clear progression of "non-target" lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator).
untitled h1
evaluation of best overall response

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.  
| Target                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Non-Target                                                                         | New     | Overall                                           | Best Overall Response when   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------|---------------------------------------------------|------------------------------|
| Lesions                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Lesions                                                                            | Lesions | Response                                          | Confirmation is Required*    |
| CR                                                                                                                                                                                                                                                                                                                                                                                                                                                        | CR                                                                                 | No      | CR                                                | >4 wks. Confirmation**       |
| CR                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Non                                                                                    |         |                                                   |                              |
| CR/Non-PD                                                                                                                                                                                                                                                                                                                                                                                                                                                 | No                                                                                 | PR      | >4 wks. Confirmation**                            |                              |
| CR                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Not                                                                                | No      | PR                                                |                              |
| evaluated                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                    |         |                                                   |                              |
| PR                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Non                                                                                    |         |                                                   |                              |
| CR/NonPD/not  evaluated                                                                                                                                                                                                                                                                                                                                                                                                                                                           | No                                                                                 | PR      |                                                   |                              |
| SD                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Non                                                                                    |         |                                                   |                              |
| CR/NonPD/not  evaluated                                                                                                                                                                                                                                                                                                                                                                                                                                                           | No                                                                                 | SD      | documented at least once >4 wks. from  baseline** |                              |
| PD                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Any                                                                                | Yes or  | PD                                                |                              |
| No                                                                                                                                                                                                                                                                                                                                                                                                                                                        | no prior SD, PR or CR                                                              |         |                                                   |                              |
| Any                                                                                                                                                                                                                                                                                                                                                                                                                                                       | PD***                                                                              | Yes or  | PD                                                |                              |
| No                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                    |         |                                                   |                              |
| Any                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Any                                                                                | Yes     | PD                                                |                              |
| *                                                                                                                                                                                                                                                                                                                                                                                                                                                         | See RECIST 1.1 manuscript for further details on what is evidence of a new lesion. |         |                                                   |                              |
| **                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Only for non-randomized trials with response as primary endpoint.                  |         |                                                   |                              |
| *** In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as disease progression. Note: Patients with a global deterioration of health status requiring discontinuation of treatment without objective  evidence of disease progression at that time should be reported as "symptomatic deterioration." Every effort  should be made to document the objective progression even after discontinuation of treatment. |                                                                                    |         |                                                   |                              |  
For Patients with Measurable Disease (i.e., Target Disease)  
| For Patients with Non-Measurable Disease (i.e., Non-Target Disease)                                                                                                                                                                            |             |                  |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------|
| Non-Target Lesions                                                                                                                                                                                                                             | New Lesions | Overall Response |
| CR                                                                                                                                                                                                                                             | No          | CR               |
| Non-CR/non-PD                                                                                                                                                                                                                                  | No          | Non-CR/non-PD*   |
| Not all evaluated                                                                                                                                                                                                                              | No          | not evaluated    |
| Unequivocal PD                                                                                                                                                                                                                                 | Yes or No   | PD               |
| Any                                                                                                                                                                                                                                            | Yes         | PD               |
| * 'Non-CR/non-PD' is preferred over 'stable disease' for non-target disease since SD is increasingly used  as an endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be  measured is not advised |             |                  |
untitled h1
duration of response

Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.  
Duration of stable disease: Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements.
untitled h1
appendix iii- strong cyp3a4 inducers

Carbamezepine Dexamethasone Ethosuximide Glucocorticoids Griseofulvin Phenytoin Primidone Progesterone Rifabutin Rifampin Nafcillin Nelfinavir Nevirapine Oxcarbazepine Phenobarbital Phenylbutazone Rofecoxib (mild)
St John's wort Sulfadimidine Sulfinpyrazone Troglitazone
appendix iv - potential risks
pembrolizumab common

**Dermatologic:** Pruritus (11% to 28% ), Rash, Immune-mediated (17% to 42% ) **Endocrine metabolic:** Hypercholesterolemia (Non-small cell lung cancer, 20% ), Hyperglycemia
(40% to 48% ), Hypertriglyceridemia (23% to 25% ), Hypoalbuminemia (32% to 34% ), Hyponatremia
(10% to 38% )
**Gastrointestinal:** Constipation (15% to 51% ), Decrease in appetite (16% to 31% ), Diarrhea (14% to 37% ), Nausea (13% to 68% )
**Hepatic:** Alkaline phosphatase raised (Non-small cell lung cancer, 26% ), AST/SGOT level raised
(20% to 24% )
**Musculoskeletal:** Arthralgia (10% to 18% ), Musculoskeletal pain (21% to 32% ) **Respiratory:** Cough (15% to 24% ), Dyspnea (11% to 39% )
**Other:** Fatigue (20% to 71% )
appendix iv - potential risks
serious

**Cardiovascular:** Vasculitis, Immune-mediated (Less than 1% )
**Dermatologic:** Bullous pemphigoid (Less than 1% ), Erythroderma (Less than 1% )
**Endocrine metabolic:** Hypophysitis, Immune-mediated (0.6% ) **Hematologic:** Anemia, Grade 3 or 4 (2% to 8% ), Hemolytic anemia, Immune-mediated (Less than 1% )
**Hepatic:** Hepatitis, Immune-mediated (0.7% ), Pancreatitis, Immune-mediated (Less than 1% ),
Veno-occlusive disease of the liver, Immune-mediated (9% )
**Immunologic:** Graft versus host disease, Immune-mediated (26% ) **Musculoskeletal:** Eaton-Lambert syndrome, Rhabdomyolysis **Neurologic:** Confusional state (Head and neck cancer, 2% or more ) **Ophthalmic:** Optic neuritis, Uveitis, Immune-mediated (Less than 1% ) **Renal:** Nephritis, Immune-mediated (0.3% ), Renal failure
**Respiratory:** Pleural effusion (2% or more ), Pneumonia (2% or more ), Pneumonitis, Immunemediated (3.4%), Respiratory failure (Head and neck cancer, 2% or more )
**Other:** Infusion reaction (0.2% ), Sepsis (Up to 10% )
appendix iv - potential risks
nivolumab

Common
**Dermatologic:** Pruritus (10% to 28% ), Rash
**Endocrine metabolic:** Hyperglycemia (Urothelial carcinoma, 42% ), Hyperkalemia (15% to 30% ),
Hypocalcemia (23% to 29% ), Hyponatremia (25% to 41% ), Serum cholesterol raised (Renal cell carcinoma, 21% ), Serum triglycerides raised (Renal cell carcinoma, 32% )
**Gastrointestinal:** Abdominal pain, Constipation (10% to 23% ), Decrease in appetite (22% to 28%
), Nausea (20% to 28% ), Vomiting (12% to 28% )
**Hematologic:** Anemia, All Grades (39% to 40% ), Lymphocytopenia, All Grades (37% to 42% ) **Hepatic:** Alkaline phosphatase raised (Urothelial carcinoma, 33% ), ALT/SGPT level raised
(Urothelial carcinoma, 18%), AST/SGOT level raised (Urothelial carcinoma, 24% )
**Musculoskeletal:** Arthralgia (10% to 21% ), Backache (Renal cell carcinoma, 21% ),
Musculoskeletal pain
**Neurologic:** Asthenia, Headache (17% to 23% ), Peripheral neuropathy (Up to 12% ) **Renal:** Serum creatinine raised (Urothelial carcinoma, 39% )
**Respiratory:** Cough (10% to 36% ), Dyspnea (2% to 20% ), Upper respiratory infection
**Other:** Fatigue (49% )
Serious
**Cardiovascular:** Myocarditis, Immune-mediated (Less than 1% ), Vasculitis, Immune-mediated
(Less than 1% )
**Dermatologic:** Rash, Immune-mediated (9% to 22.6% ), Stevens-Johnson syndrome, Immunemediated, Toxic epidermal necrolysis, Immune-mediated
**Endocrine metabolic:** Adrenal insufficiency, Immune-mediated (1% to 5% ), Diabetic ketoacidosis, Hypercalcemia (Renal cell carcinoma, 19% ), Hyperthyroidism, Immune-mediated
(2.7% to 8% ), Hypophysitis, Immune-mediated (0.6% to 9% ), Hypopituitarism, Immune-mediated (Less than 1% ), Hypothyroidism, Immune-mediated, Thyroiditis, Immune-mediated, Type 1 diabetes mellitus, Immune-mediated (0.9% to 1.5% )
**Gastrointestinal:** Colitis, Immune-mediated (Monotherapy, 2.9%; combined with ipilimumab, 26%
), Diarrhea (17% to 52% ), Duodenitis, Immune-mediated (Less than 1% ), Gastritis, Immunemediated (Less than 1% ), Pancreatitis, Immune-mediated (Less than 1% ), Perforation of colon
(Less than 10% )
**Hematologic:** Anemia, Grade 3 or 4 (1.1% to 8% ), Lymphocytopenia, Grade 3 or 4 (4.3% to 9%
), Neutropenia, Grade 3 or 4 (1.1% )
**Hepatic:** Hepatitis, Immune-mediated (1.8% to 13% ) **Immunologic:** Histiocytic necrotizing lymphadenitis, Immune-mediated (Less than 1% ),
Sarcoidosis, Immune-mediated (Less than 1% )
**Musculoskeletal:** Eaton-Lambert syndrome, Immune-mediated (Less than 1% ), Myositis, Immune-mediated (Less than 1% ), Rhabdomyolysis, Immune-mediated (Less than 1% )
**Neurologic:** Demyelination of spinal cord, Immune-mediated (Less than 1% ), Encephalitis, Immune-mediated (0.2% ), Guillain-Barré syndrome, Immune-mediated (Less than 1% ),
Neuropathy, Immune-mediated (Less than 1% )
**Ophthalmic:** Uveitis, Immune-mediated (Less than 1% )
**Renal:** Nephritis, Immune-mediated, Renal impairment, Immune-mediated, Urinary tract infectious disease (Urothelial carcinoma, 17% )
**Respiratory:** Pleural effusion (2% or greater ), Pneumonitis, Immune-mediated (3.1% to 6%),
Pulmonary embolism (Non-small cell lung cancer, 4.2% ), Respiratory failure (2% or greater),
Respiratory tract infection (2% or greater )
**Other:** Sepsis (2% or greater )
appendix iv - potential risks
atezolizumab common

**Gastrointestinal:** Constipation (15% to 21% ), Decrease in appetite (24% to 35% ), Diarrhea, Immune-mediated (18% to 24% ), Nausea (22% to 25% )
**Respiratory:** Cough (14% to 30% ), Dyspnea (12% to 32% )
**Other:** Fatigue (52% )
appendix iv - potential risks
serious

**Cardiovascular:** Myocarditis (Up to 1% )
**Endocrine metabolic:** Adrenal insufficiency, Immune-mediated (0.4% ), Diabetes mellitus, Immunemediated (0.2% to 0.3% ), Hyperthyroidism (0.6% to 1.1% ), Hypophysitis, Immune-mediated (0.2% ),
Hypothyroidism (2.5% to 4.2% )
**Gastrointestinal:** Abdominal pain (15% to 17% ), Colitis, Immune-mediated, Pancreatitis, Immunemediated (0.1% )
**Hepatic:** Hepatitis, Immune-mediated (0.9% to 1.3% )
**Musculoskeletal:** Eaton-Lambert syndrome, Myasthenia gravis, Immune-mediated
**Neurologic:** Encephalitis, Guillain-Barré syndrome, Immune-mediated, Meningitis **Renal:** Hematuria (14% ), Urinary tract infectious disease (17% to 22% ) **Respiratory:** Interstitial lung disease, Pneumonitis, Immune-mediated
**Other:** Fever (14% to 21% ), Infectious disease (37.7% to 43% ), Infusion reaction (1.6% to 1.7% )
appendix iv - potential risks
appendix v - daily drug

The study drug exemestane should be taken with a meal once a day, every day until you are told to stop. If you forget to take a dose by more than 8 hour after the scheduled time or vomit after you take a dose, you should skip the dose and only take the next schedule dose. If this occurs, record a "0" in the time taken column and indicate the reason the dose was missed under the notes column. Please bring this completed drug log and your study drug bottles (including any unused medication) with you to each appointment. If you have any questions, please contact the study coordinator _________________ at ________________.  
| coordinator _________________ at ________________. date time of  verify 1 tablet  dose taken (if dose  missed record 0) side effects and notes   |
|--------------------------------------------------------------------------------------------------------------------------------------------------|  
| date   | time of                          | verify 1 tablet        |
|--------|----------------------------------|------------------------|
| dose   | taken (if dose  missed record 0) | side effects and notes |  
Upon return of the completed log and drug reconciliation:
Research Staff Signature: Date Reviewed:
appendix vi - promis -29
promis-29 profile v2.0

| Please respond to each question or statement by marking one box per row.   |                           |              |            |                       |        |    |
|----------------------------------------------------------------------------|---------------------------|--------------|------------|-----------------------|--------|----|
| Without                                                                    | With a                    | With         | With       |                       |        |    |
| Physical Function                                                          | any                       | little       | some       | much                  | Unable |    |
| difficulty                                                                 | difficulty                | difficulty   | difficulty | to do                 |        |    |
| Are you able to do chores such as                                          | →                         | □            | □          | □                     | →      |    |
| 1                                                                          | vacuuming or yard work?.  |              |            |                       |        |    |
| Are you able to go up and down stairs at a                                 | →                         | □            | →          | □                     | □      |    |
| 2                                                                          | normal pace?              |              |            |                       |        |    |
| Are you able to go for a walk of at least                                  | →                         | □            | →          | □                     | □      |    |
| s                                                                          | 15 minutes?.              |              |            |                       |        |    |
| Are you able to run errands and shop? .....                                | →                         | □            | □          | □                     | □      |    |
| .                                                                          | Anxiety                   |              |            |                       |        |    |
| In the past 7 days…                                                        | Never                     | Rarch        | Sometimes  | Often                 | Always |    |
| s                                                                          | I felt fearful            | →            | →          | →                     | →      | -  |
| I found it hard to focus on anything other                                 | →                         | □            | →          | →                     | □      |    |
| e                                                                          | than my anxiety           | →            | □          | □                     | →      | □  |
| r                                                                          | My worries overwhelmed me | →            | □          | →                     | □      | □  |
| o                                                                          | I felt uneasy             |              |            |                       |        |    |
| Depression                                                                 |                           |              |            |                       |        |    |
| In the past 7 days...                                                      | Never                     | Rarely       | Sometime   | Often                 | Always |    |
| →                                                                          | →                         | -            | -          | -                     |        |    |
| o                                                                          | I felt worthless .        | □            | □          | □                     | □      | □  |
| s                                                                          | I felt helpless.          | →            | □          | -                     | □      | □  |
| H                                                                          | I felt depressed          | →            | □          | -                     | -      | -  |
| I felt hopeless.                                                           |                           |              |            |                       |        |    |
| s                                                                          | Fatigue                   |              |            |                       |        |    |
| During the past 7 days…                                                    | Not at all                | A little bit | Somewhat   | Quite a bit Very much |        |    |
| 1                                                                          | I feel fatigued           | →            | -          | →                     | →      | □  |
| I have trouble starting things because I                                   | □                         | □            | →          | □                     | □      |    |
| 1                                                                          | am tired                  |              |            |                       |        |    |  
Participant Format © 2008-2013 PROMIS Health Organization and PROMIS Cooperative Group Page 1 of 3 e  
| Fatigue                                    |                                               |              |           |                        |           |    |
|--------------------------------------------|-----------------------------------------------|--------------|-----------|------------------------|-----------|----|
| In the past 7 days..                       | Not at all                                    | A little bit | Somewhat  | Quiteral bit Very much |           |    |
| -                                          | →                                             | →            | □         | →                      |           |    |
| s                                          | How run-down did you feel on average? ...     | →            | →         | →                      | □         | -  |
| n                                          | How fatigued were you on average? .........   |              |           |                        |           |    |
| Sleep Disturbance                          |                                               |              |           |                        |           |    |
| In the past 7 days..                       | Very poor                                     | Poor         | Fair      | Good                   | Very good |    |
| →                                          | →                                             | →            | →         | →                      |           |    |
| r                                          | My sleep quality was ........                 |              |           |                        |           |    |
| In the past 7 days…                        | Not at all                                    | A little bit | Somewhat  | Quite a bit            | Very much |    |
| →                                          | →                                             | -            | →         | →                      |           |    |
| v                                          | My sleep was refreshing.                      | →            | □         | -                      | □         | →  |
| I had a problem with my sleep              |                                               |              |           |                        |           |    |
| r                                          | →                                             | □            | □         | □                      | →         |    |
| ss                                         | I had difficulty falling asleep               |              |           |                        |           |    |
| Ability to Participate in Social Roles     |                                               |              |           |                        |           |    |
| and Activities                             | Never                                         | Rarely       | Sometimes | Usually                | Always    |    |
| I have trouble doing all of my regular     | □                                             | □            | →         | →                      | →         |    |
| 2                                          | leisure activities with others ....           |              |           |                        |           |    |
| I have trouble doing all of the family     | →                                             | →            | □         | →                      | -         |    |
| 22                                         | activities that I want to do .....            |              |           |                        |           |    |
| I have trouble doing all of my usual work  | -                                             | □            | -         | →                      | -         |    |
| s                                          | (include work at home) ........               |              |           |                        |           |    |
| I have trouble doing all of the activities | -                                             | →            | □         | □                      | →         |    |
| 24                                         | with friends that I want to do .....          |              |           |                        |           |    |
| Pain Interference                          |                                               |              |           |                        |           |    |
| In the past 7 days..                       | Not at all                                    | A little bit | Somewhat  | Quite a bit            | Very much |    |
| How much did pain interfere with your      | □                                             | →            | □         | →                      | -         |    |
| 22                                         | day to day activities?                        |              |           |                        |           |    |
| How much did pain interfere with work.     | □                                             | □            | □         | □                      | □         |    |
| s                                          | around the home? .                            |              |           |                        |           |    |
| How much did pain interfere with your      | →                                             | □            | □         | □                      | →         |    |
| 27                                         | ability to participate in social activities?. |              |           |                        |           |    |
| How much did pain interfere with your      | □                                             | □            | -         | □                      | -         |    |
| sa                                         | household chores?                             |              |           |                        |           |    |  
Participant Format © 2008-2013 PROMIS Health Organization and PROMIS Cooperative Group Page 2 of 3 PROMIS–29 Profile v2.0  
| Pain Intensity                  |            |    |    |    |    |    |    |    |    |    |    |
|---------------------------------|------------|----|----|----|----|----|----|----|----|----|----|
| In the past 7 days…             |            |    |    |    |    |    |    |    |    |    |    |
| How would you rate your pain on |            |    |    |    |    |    |    |    |    |    |    |
| re                              | □          | □  | D  | □  |    | □  | □  | □  | □  | □  | □  |
| average?                        | o          | i  | 2  | 3  | 4  | s  | 6  | 7  | s  | 9  | 10 |
| No                              | Worst      |    |    |    |    |    |    |    |    |    |    |
| pain                            | imaginable |    |    |    |    |    |    |    |    |    |    |
| pain                            |            |    |    |    |    |    |    |    |    |    |    |  
Participant Format © 2008-2013 PROMIS Health Organization and PROMIS Cooperative Group Page 3 of 31