untitled h1
evaluation of target lesions

| 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.                                                                                                                                                      |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.  
| For Patients with Measurable Disease (i.e., Target Disease)                                                                                                                                   |                                                                                    |          |                           |                                  |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------|---------------------------|----------------------------------|
| Target                                                                                                                                                                                        | Non-Target Lesions                                                                 | New      | Overall                   | Best Overall Response when       |
| Lesions                                                                                                                                                                                       | Lesions                                                                            | Response | Confirmation is Required* |                                  |
| CR                                                                                                                                                                                            | CR                                                                                 | No       | CR                        | >4 wks. Confirmation**           |
| CR                                                                                                                                                                                            | Non-CR/Non-PD                                                                      | No       | PR                        |                                  |
| CR                                                                                                                                                                                            | Not evaluated                                                                      | No       | PR                        | >4 wks. Confirmation**           |
| PR                                                                                                                                                                                            | Non-CR/Non-PD/not                                                                  | No       | PR                        |                                  |
| evaluated                                                                                                                                                                                     |                                                                                    |          |                           |                                  |
| SD                                                                                                                                                                                            | Non-CR/Non-PD/not                                                                  | No       | SD                        | documented at least once >4 wks. |
| evaluated                                                                                                                                                                                     | 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. |                                                                                    |          |                           |                                  |  
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 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 |             |                  |
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
progression-free survival

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.  
| See Section 9.2 for time points                     | based on CTCAE v4                                               |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
|-----------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Patient Initials: _______                           | Date of Assessment: _________                                   | Assessment Time Point: _________                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Toxicity                                            | Grade 0                                                         | Grade 1                                                                               | Grade 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Grade 3                                                                                                                                                            | Grade 4                         |
| ALT-803 Injection                                   | None                                                            | Tenderness with or                                                                    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| site reaction                                       | without associated  symptoms (e.g., warmth,  erythema, itching) | Pain; lipodystrophy; edema;                                                           | Ulceration or necrosis; severe                                                                                                                                                                                                                                                                                                                                                                                                                                         | Life-threatening consequences;                                                                                                                                     |                                 |
| phlebitis                                           | tissue damage; operative                                        | urgent intervention indicated                                                         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| intervention indicated                              |                                                                 |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Abdominal Pain                                      | None                                                            | Asymptomatic but                                                                      | Moderate pain; limiting                                                                                                                                                                                                                                                                                                                                                                                                                                                | Severe pain; limiting self care                                                                                                                                    | --------------                  |
| (IP related)                                        | distention                                                      | instrumental ADL                                                                      | ADL                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                    |                                 |
| Dyspnea                                             | None or                                                         | Shortness of breath with                                                              | Shortness of breath with minimal                                                                                                                                                                                                                                                                                                                                                                                                                                       | Shortness of breath at rest;                                                                                                                                       | Life-threatening consequences;  |
| no change                                           | moderate exertion                                               | exertion; limiting instrumental ADL                                                   | limiting self care ADL                                                                                                                                                                                                                                                                                                                                                                                                                                                 | urgent intervention indicated                                                                                                                                      |                                 |
| Hypoxia                                             | None                                                            | ………………                                                                                | Decreased O2 saturation with  exercise (e.g., pulse oximeter <  88%) intermittent supplemental  oxygen                                                                                                                                                                                                                                                                                                                                                                 | Decreased oxygen saturation at                                                                                                                                     | Life-threatening airway         |
| rest (e.g., pulse oximeter < 88%                    | compromise; urgent                                              |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| or PaO2 ≤ 55 mm Hg)                                 | intervention indicated (e.g.,  tracheotomy or intubation)       |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Fever                                               | None                                                            | 38.0 - 39.0◦ C (100.4 -                                                               | > 39.0 - 40.0◦C (102.3 - 104.0◦F)                                                                                                                                                                                                                                                                                                                                                                                                                                      | > 40.0 ◦ C (>104.0◦ F) for ≤ 24 hrs                                                                                                                                | > 40.0 ◦ C (>104.0◦ F) for > 24 |
| 102.2◦ F)                                           | hrs                                                             |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Chills                                              | None                                                            | Mild sensation of cold;                                                               | Moderate tremor of the entire body;                                                                                                                                                                                                                                                                                                                                                                                                                                    | Severe or prolonged, not                                                                                                                                           | ………………………                       |
| shivering; chattering of teeth  narcotics indicated | responsive to narcotics                                         |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Hypertension                                        | None                                                            | Pre-hypertension (systolic  BP 120 - 139 mm Hg or  diastolic BP 80 - 89 mm  Hg)       | Stage 1 hypertension (systolic BP  140 - 159 mm Hg or diastolic BP 90 -  99 mm Hg); medical intervention  indicated; recurrent or persistent ≥  24 hrs); symptomatic increase by  >20 mm Hg (diastolic) or to >140/90  mm Hg if previously WNL;  monotherapy indicated.  Stage 2 hypertension (systolic BP  ≥ 160 mm Hg or diastolic BP ≥  100 mm Hg); medical intervention  indicated; more than one drug or  more intensive therapy than  previously used indicated. | Life-threatening  consequences (e.g.,  malignant hypertension,  transient or permanent  neurologic deficit,  hypertensive crisis); urgent  intervention indicated. |                                 |
| Hypotension                                         | None                                                            | Asymptomatic, intervention  Non-urgent medical                                        | Medical intervention or                                                                                                                                                                                                                                                                                                                                                                                                                                                | Life-threatening and urgent                                                                                                                                        |                                 |
| not indicated                                       | intervention indicated                                          | hospitalization indicated                                                             | intervention indicated                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                    |                                 |
| Edema                                               | None                                                            | Localized to dependent                                                                | Moderate localized edema                                                                                                                                                                                                                                                                                                                                                                                                                                               | Severe localized edema and                                                                                                                                         | ………………………                       |
| areas, no disability or                             | and intervention indicated;                                     | intervention indicated; limiting self                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| functional impairment                               | limiting instrumental ADL                                       | care ADL                                                                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Pneumonitis                                         | None                                                            | Asymptomatic; clinical or  diagnostic observations  only; intervention not  indicated | Symptomatic; medical                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Severe symptoms; limiting self                                                                                                                                     | Life-threatening respiratory    |
| intervention indicated; limiting                    | care ADL; oxygen indicated                                      | compromise; urgent                                                                    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| instrumental ADL                                    | intervention indicated (e.g.  intubation or tracheotomy)        |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Headache                                            | None                                                            | Mild pain                                                                             | Moderate pain; limiting                                                                                                                                                                                                                                                                                                                                                                                                                                                | Severe pain; limiting self care                                                                                                                                    | ………………………                       |
| instrumental ADL                                    | ADL                                                             |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Confusion                                           | None                                                            | Mild disorientation                                                                   | Moderate disorientation; limiting                                                                                                                                                                                                                                                                                                                                                                                                                                      | Severe disorientation; limiting self                                                                                                                               | Life-threatening                |
| (Altered Mental                                     | instrumental ADL                                                | care ADL                                                                              | consequences; urgent                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                    |                                 |
| Status)                                             | intervention indicated                                          |                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Rash                                                | None                                                            | Covering < 10% body                                                                   | Covering 10-30% body surface                                                                                                                                                                                                                                                                                                                                                                                                                                           | >30% body surface area (BSA)                                                                                                                                       | Generalized exfoliative,        |
| surface area (BSA)                                  | area (BSA)                                                      | ulcerative, or bullous dermatitis                                                     |                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| Gait Disturbance                                    | None                                                            | Mild change in gait (eg,                                                              | Moderate change in gait (eg, widebased, limping or hobbling);                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                    |                                 |
| wide-based, limping or  hobbling)                   | assistance device indicated;  limiting instrumental ADL         | Disabling; limiting self care ADL                                                     | ………………………                                                                                                                                                                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                    |                                 |  
Person Completing Form: ADL = activities of daily living
appendix v - alt-803 injection
progression-free survival

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

| INTRAPERITONEAL (IP) INJECTION  Patient Number*                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Date of Study Drug IP Infusion*   | ________/_________/________   | *To be completed by the site.   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------|---------------------------------|
| Please answer all questions below daily for 7 days, beginning with day of treatment. Be sure to bring back this completed diary to your next clinic visit.  Day of Study  Instructions  Drug IP Infusion  ____/____/_________  Day 1  Post Infusion  ____/____/_________ Day 2  Post Infusion  ____/____/_________  Day 3  Post Infusion  ____/____/_________ Day 4  Post Infusion  ____/____/________ Day 5  Post Infusion  ___/___/________ Day 6  Post Infusion  ____/____/_________ Check:  Yes or No If yes, tell us if the pain  is mild, moderate or  severe  Yes No  Mild  Moderate  Severe  Yes No  Mild  Moderate  Severe  Yes No  Mild  Moderate  Severe  Yes No  Mild  Moderate  Severe  Yes No  Mild  Moderate  Severe  Yes No  Mild  Moderate  Severe  Yes No  Mild  Moderate  Severe  1. Have you  experienced any  abdominal pain? Yes No Asymptomatic  (visually  distended but  not bothersome)  Yes No Asymptomatic  (visually  distended but  not bothersome)  Yes No Asymptomatic  (visually  distended but  not bothersome)  Yes No Asymptomatic  (visually  distended but  not bothersome)  Yes No Asymptomatic  (visually  distended but  not bothersome)  Yes No Asymptomatic  (visually  distended but  not bothersome)  Yes No Asymptomatic  (visually  distended but  not bothersome)  Check:  Yes or No If yes, tell us if the  extent of the  abdominal distention 1. Have you  experienced any  abdominal  distention?  Symptomatic:  Symptomatic:  Symptomatic:  Symptomatic:  Symptomatic:  Symptomatic:  Symptomatic:  Severe  discomfort  Severe  discomfort Severe  discomfort Severe  discomfort Severe  discomfort Severe  discomfort Severe  discomfort Yes No Name(s):  Yes No Name(s):  Yes No Name:  Yes No Name:  Yes No Name:  Yes No Name:  Yes No Name:  Check:  Yes or No Provide name of  medication(s)  4. Have you taken any  medication for  abdominal pain? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Check:  Yes or No If yes, tell us if the  chills are mild,  moderate or severe 5. Have you  experienced any  chills?   Mild  Moderate   Severe  Mild  Moderate   Severe  Mild  Moderate   Severe  Mild  Moderate   Severe  Mild  Moderate   Severe  Mild  Moderate   Severe  Mild  Moderate   Severe Yes No Yes No Yes No Yes No Yes No Yes No Yes No Check:  Yes or No If your temperature is  101°F for more than  24 hours notify your  study doctor or the  research staff.  6. Record your daily  temperature upon  waking   (do not drink anything 5  minutes before taking your  temperature)  ________°F ________°F ________°F ________°F ________°F ________°F ________°F Time:  ____:____  AM / PM  Time:  ____:____  AM / PM  Time:  ____:____  AM / PM  Time:  ____:____  AM / PM  Time:  ____:____  AM / PM  Time:  ____:____  AM / PM  Time:  ____:____  AM / PM  Grading Abdominal Pain Grading Chills |                                   |                               |                                 |  
Grading Abdominal Pain **Grading Chills**
Mild - Noticeable, does not interfere with activity Mild - Mild sensitive of cold, shivering, chattering of teeth Moderate - Interferes with activity, limiting activities of daily living Moderate - Moderate tremor of entire body, medication taken Severe - Severely limiting self-care activities of daily living, incapacitating Severe - Prolonged or severe, does not respond to medication