untitled h1
completion of pregnancy follow-up report

| Completion of Pregnancy Follow-up Report Form                                    |                                                                  |                                                                   |
|----------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------|
| If the outcome of the pregnancy is abnormal (e.g., spontaneous abortion [any     |                                                                  |                                                                   |
| congenital anomaly detected in an aborted fetus must be documented], stillbirth, |                                                                  |                                                                   |
| neonatal death, or congenital anomaly [including that in an aborted fetus]), the |                                                                  |                                                                   |
| Investigator must report the abnormal outcome as an AE.  If the abnormal         |                                                                  |                                                                   |
| outcome meets any of the serious criteria, it must be reported as an SAE to      |                                                                  |                                                                   |
| Celgene Drug Safety using the SAE Report Form.                                   |                                                                  |                                                                   |
| Header and Demographic                                                           | .                                                                | Enter the Protocol Number in the space provided                   |
| Information                                                                      | Record the date the site first became aware of the pregnancy,    |                                                                   |
| .                                                                                | suspected pregnancy or exposure                                  |                                                                   |
| .                                                                                | Record the name of the Principal Investigator at the site        |                                                                   |
| .                                                                                | Record the subject initials as recorded in the Case Report       |                                                                   |
| Form                                                                             |                                                                  |                                                                   |
| Record the 3-digit site number assigned to the study site                        |                                                                  |                                                                   |
| .                                                                                | Record the 4-digit subject number that was assigned to the       |                                                                   |
| .                                                                                | subject                                                          |                                                                   |
| Record the subject's age at the time of the pregnancy                            |                                                                  |                                                                   |
| .                                                                                | Record the sex of the study subject, regardless of whether the   |                                                                   |
| pregnant female is the study subject or not                                      |                                                                  |                                                                   |
| .                                                                                | Record subject's race; check one box, unless the race is not     |                                                                   |
| listed then check other and specify                                              |                                                                  |                                                                   |
| Summary of Diagnostic                                                            | .                                                                | Indicate if any diagnostic tests were performed since the initial |
| Tests Information                                                                | report by checking "None" or listing the tests and their results |                                                                   |
| as appropriate                                                                   |                                                                  |                                                                   |
| Pregnancy Complication                                                           | Indicate if any pregnancy complications have occurred since      |                                                                   |
| Information                                                                      | the initial report by checking "None" or summarizing the         |                                                                   |
| complications as appropriate                                                     |                                                                  |                                                                   |
| Ongoing Pregnancy Status                                                         | Record the number of weeks the female is pregnant OR             |                                                                   |
| .                                                                                |                                                                  |                                                                   |
| OR Outcome Information                                                           | .                                                                | Check the applicable outcome                                      |
| .                                                                                | Provide the date of delivery or termination using the following  |                                                                   |
| format: dd/mmm/yyy                                                               |                                                                  |                                                                   |
| Provide the birth weight                                                         |                                                                  |                                                                   |
| .                                                                                | Indicate the method of delivery by checking the appropriate      |                                                                   |
| .                                                                                | box                                                              |                                                                   |
| Provide the gestational age at delivery                                          |                                                                  |                                                                   |
| Provide the respective APGAR scores at 1, 5 and/or 10                            |                                                                  |                                                                   |
| minutes                                                                          |                                                                  |                                                                   |
| Comments Section                                                                 | .                                                                | Record any additional information not already provided            |
| including:  changes in concomitant medications since previous                    |                                                                  |                                                                   |
| report and medications at delivery, complications after delivery                 |                                                                  |                                                                   |
| or discovery of an anomaly                                                       |                                                                  |                                                                   |  
  
| Form Completion                                            | .                                                                | Print the name of the Investigator and obtain the Investigator's   |
|------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------|
| Information                                                | signature                                                        |                                                                    |
| .                                                          | Record the date (dd/mmm/yyy) the Investigator signed the         |                                                                    |
| report                                                     |                                                                  |                                                                    |
| .                                                          | Print the name of the reporter, include the reporter's signature |                                                                    |
| .                                                          | Record the date (dd/mmm/yyy) the reporter signed the report      |                                                                    |
| Document the reporter's phone number, fax number and email |                                                                  |                                                                    |
| .                                                          | address                                                          |                                                                    |  
| Page 1 of 1                                                                                                                        |                                                                                                          |                            |                |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------|----------------|
| Pregnancy reports must be sent to                                                                                                  |                                                                                                          |                            |                |
| PREGNANCY                                                                                                                          | Celgene Drug  Safety IMMEDIATELY                                                                         |                            |                |
| INITIAL REPORT                                                                                                                     | Protocol No.:  MRZ-CL-BRAIN-NCI-12815                                                                    |                            |                |
| Date site first became                                                                                                             | Investigator Name:                                                                                       |                            |                |
| aware of Pregnancy:                                                                                                                | YYY                                                                                                      |                            |                |
| Subject Initials (F, M, L):                                                                                                        | Site No.:                                                                                                | Subject No.:               | Subject's Age: |
| Sex of Subject:                                                                                                                    | Screening Pregnancy Test:                                                                                |                            |                |
| Negative?                                                                                                                          | - No                                                                                                     | YYY                        |                |
| - Pregnancy of Subject                                                                                                             | Last Menstrual Period:                                                                                   |                            |                |
| Partner                                                                                                                            | YYY                                                                                                      |                            |                |
| - Suspected Pregnancy                                                                                                              | ❏ Exposure of a Pregnant                                                                                 | Total # prior pregnancies: |                |
| Female                                                                                                                             | Total # prior live births:                                                                               |                            |                |
| Total # terminations (spontaneous and elective):                                                                                   |                                                                                                          |                            |                |
| Race:                                                                                                                              | History of congential anomalies with prior pregnancies?                                                  |                            |                |
| □ Other, specify                                                                                                                   | History of familial congential anomalies?                                                                |                            |                |
| Concomitant Medications: (at time of study entry, during study treatment and at conception)  Attach additional sheets as necessary |                                                                                                          |                            |                |
| Study Drug Name:                                                                                                                   | Date of First Dose:                                                                                      | Date of Last Dose:         |                |
| Method of Birth Control:    (Check (√) all that apply)                                                                             |                                                                                                          |                            |                |
| □ Abstinence                                                                                                                       | ❏ Intrauterine Device (IUD)                                                                              | - Sterilization (female).  |                |
| □ Condom                                                                                                                           | - Oral Contraceptive                                                                                     | - Sterilization (male)     |                |
| ❏ Diaphragm                                                                                                                        | - Rhythm Method                                                                                          | □ None                     |                |
| - Depo Contraceptive (e.g., Norplant, Depo-Provera)                                                                                | - Other:                                                                                                 |                            |                |
| Pregnancy Initially Diagnosed By:                                                                                                  | - Home Urine Test                                                                                        | ❏ Office Urine Test        | □ Serum Test   |
| Date of Pregnancy Test:                                                                                                            | yyy                                                                                                      |                            |                |
| Female is Currently:                                                                                                               | weeks pregnant  OR  [ ] No longer Pregnant  (If no longer pregnant, complete Pregnancy Follow-up Report) |                            |                |
| Female has Elected to:                                                                                                             |                                                                                                          |                            |                |
| - Terminate Pregnancy (Date Performed or Pending):                                                                                 | YYY                                                                                                      |                            |                |
| Summarize Diagnostic Tests  to Date                                                                                                | Describe Complications with Pregnancy  to Date                                                           |                            |                |
| (e.g., ultrasound, amniocentesis):                                                                                                 | - None                                                                                                   | □ None                     |                |
| Investigator's Name and Signature:                                                                                                 | Date:                                                                                                    | .                          |                |
| Reporter's Name and Signature:                                                                                                     | Date:                                                                                                    | .                          |                |
| Reporter's Phone Number:                                                                                                           | Reporter's Fax Number:                                                                                   | Reporter's E-mail Address: |                |
| NOTE: Please use the first three letters of the month (e.g.: JAN)                                                                  | INIT PREG Form  26 May 2010                                                                              |                            |                |