+--------+---------+---------+-------------+------+---------+-------+
| Na     |         |         |             | Divi |         |       |
| tional |         |         |             | sion |         |       |
| Inst   |         |         |             | of   |         |       |
| itutes |         |         |             | Ca   |         |       |
| of     |         |         |             | ncer |         |       |
| Health |         |         |             | T    |         |       |
|        |         |         |             | reat |         |       |
| Na     |         |         |             | ment |         |       |
| tional |         |         |             | and  |         |       |
| Cancer |         |         |             | D    |         |       |
| Ins    |         |         |             | iagn |         |       |
| titute |         |         |             | osis |         |       |
|        |         |         |             |      |         |       |
| ##     |         |         |             | Ca   |         |       |
|        |         |         |             | ncer |         |       |
| ## Ge  |         |         |             | The  |         |       |
| neric  |         |         |             | rapy |         |       |
| CTC Ve |         |         |             | Ev   |         |       |
| rsion  |         |         |             | alua |         |       |
| 2.0 Da |         |         |             | tion |         |       |
| ta Col |         |         |             | Pro  |         |       |
| lectio |         |         |             | gram |         |       |
| n Form |         |         |             |      |         |       |
+--------+---------+---------+-------------+------+---------+-------+
| ###    |         |         |             |      |         |       |
| ### Pl |         |         |             |      |         |       |
| ease P |         |         |             |      |         |       |
| rint o |         |         |             |      |         |       |
| r Type |         |         |             |      |         |       |
+--------+---------+---------+-------------+------+---------+-------+
| **Pr   |         | **      |             |      | *       |       |
| otocol |         | Patient |             |      | *Course |       |
| No.:** |         | ID      |             |      | No.:**  |       |
|        |         | No.:**  |             |      |         |       |
+--------+---------+---------+-------------+------+---------+-------+

  ------------------------------------------------------------------------------------------------------------------------
  **Date of                          **Category/Toxicity**               **Grade**      **\*Attribution**               
  Event**                                                                                                               
  --------- -- --------- -------- -- -------------------------------- -- ----------- -- ------------------- -------- -- --
                                                                                                                        

               **Yes**   **No**      **ALLERGY/IMMUNOLOGY**                                                             

                                     Allergic                            **1 2 3 4                          **1 2 3     
                                     reaction/hypersensitivity           5**                                4 5**       
                                     (including drug fever)                                                             

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **AUDITORY/HEARING**                                                               

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **BLOOD/BONE MARROW**                                                              

                                     Hemoglobin (Hgb)                    **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Leukocytes (total WBC)              **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Neutrophils/granulocytes            **1 2 3 4                          **1 2 3     
                                     (ANC/AGC)                           5**                                4 5**       

                                     Platelets                           **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Transfusion: platelets              **3 4 5**                          **1 2 3     
                                                                                                            4 5**       

                                     Transfusion: pRBCs                  **3 4 5**                          **1 2 3     
                                                                                                            4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **CARDIOVASCULAR (ARRHYTHMIA)**                                                    

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **CARDIOVASCULAR (GENERAL)**                                                       

                                     Cardiac-ischemia/infarction         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Cardiac left ventricular            **1 2 3 4                          **1 2 3     
                                     function                            5**                                4 5**       

                                     Hypotension                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **COAGULATION**                                                                    

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **CONSTITUTIONAL SYMPTOMS**                                                        

                                     Fatigue                             **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Weight loss                         **1 2 3**                          **1 2 3     
                                                                                                            4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        
  ------------------------------------------------------------------------------------------------------------------------

  ------------------------------------------------------------------------------------------------------------------------
  **Date of                          **Category/Toxicity**               **Grade**      **\*Attribution**               
  Event**                                                                                                               
  --------- -- --------- -------- -- -------------------------------- -- ----------- -- ------------------- -------- -- --
                                                                                                                        

               **Yes**   **No**      **DERMATOLOGY/SKIN**                                                               

                                     Alopecia                            **1 2**                            **1 2 3     
                                                                                                            4 5**       

                                     Rash/desquamation                   **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Urticaria (hives, welts, wheals)    **1 2 3**                          **1 2 3     
                                                                                                            4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **ENDOCRINE**                                                                      

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **GASTROINTESTINAL**                                                               

                                     Anorexia                            **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Dehydration                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Diarrhea                            **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Dysphagia, esophagitis,             **1 2 3 4                          **1 2 3     
                                     odynophagia (painful swallowing)    5**                                4 5**       

                                     Nausea                              **1 2 3**                          **1 2 3     
                                                                                                            4 5**       

                                     Stomatitis/pharyngitis              **1 2 3 4                          **1 2 3     
                                     (oral/pharyngeal mucositis)         5**                                4 5**       

                                     Vomiting                            **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **HEMORRHAGE**                                                                     

                                     Hemorrhage/bleeding with grade 3    **1 3 4 5**                        **1 2 3     
                                     or 4 thrombocytopenia                                                  4 5**       

                                     Hemorrhage/bleeding without         **1 3 4 5**                        **1 2 3     
                                     grade 3 or 4 thrombocytopenia                                          4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **HEPATIC**                                                                        

                                     Bilirubin                           **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     GGT                                 **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     SGOT (AST)                          **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     SGPT (ALT)                          **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **INFECTION/FEBRILE                                                                
                                     NEUTROPENIA**                                                                      

                                     Catheter-related infection          **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Febrile neutropenia (fever of       **3 4 5**                          **1 2 3     
                                     unknown origin without                                                 4 5**       
                                     clinically or microbiologically                                                    
                                     documented infection.\                                                             
                                     (ANC \<1.0 x 10^9^/L, fever \>                                                     
                                     38.5)                                                                              

                                     Infection (documented clinically    **3 4 5**                          **1 2 3     
                                     or microbiologically) with grade                                       4 5**       
                                     3 or 4 neutropenia. (ANC \< 1.0                                                    
                                     x 10^9^/L)                                                                         

                                     Infection without neutropenia       **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       
  ------------------------------------------------------------------------------------------------------------------------

  ------------------------------------------------------------------------------------------------------------------------
  **Date of                          **Category/Toxicity**               **Grade**      **\*Attribution**               
  Event**                                                                                                               
  --------- -- --------- -------- -- -------------------------------- -- ----------- -- ------------------- -------- -- --
                                                                                                                        

               **Yes**   **No**      **LYMPHATICS**                                                                     

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **METABOLIC/LABORATORY**                                                           

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **MUSCULOSKELETAL**                                                                

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **NEUROLOGY**                                                                      

                                     Neuropathy-cranial                  **2 3 4 5**                        **1 2 3     
                                                                                                            4 5**       

                                     Neuropathy-motor                    **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                     Neuropathy-sensory                  **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **OCULAR/VISUAL**                                                                  

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **PAIN**                                                                           

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **PULMONARY**                                                                      

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **RENAL/GENITOURINARY**                                                            

                                     Creatinine                          **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **SECONDARY MALIGNANCY**                                                           

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       

                                                                                                                        

               **Yes**   **No**      **SEXUAL/REPRODUCTIVE FUNCTION**                                                   

                                                                         **1 2 3 4                          **1 2 3     
                                                                         5**                                4 5**       
  ------------------------------------------------------------------------------------------------------------------------