If a pregnancy is reported, complete the Pregnancy (3501) Form to answer questions specific to the pregnancy. The option of Previously reported should only be used if the same pregnancy instance has already been reported on a Pregnancy (3501) Form that was created as an unscheduled form (“on demand”). If there is a question regarding use of this option, contact CIBMTR Center Support if there are questions.

Question 176: Was the recipient pregnant at any time in this reporting period? (Female Only)

Indicate Yes or No if the female recipient was pregnant at any time during the reporting period. If Yes, complete a Pregnancy (3501) form. See examples below.

Question 177: Was the recipient’s female partner pregnant at any time in this reporting period? (Male only)

Indicate Yes or No if the male recipient’s female partner was pregnant at any time during the reporting period. If *Ye*s, complete a Pregnancy (3501) form. See examples below.

Example 1. Recipient or recipient’s female partner becomes pregnant at day +68. It is reported at the time the 100-day Form Cellular Therapy Essential Data Follow-Up (4100) form is completed. Question 180 or 181 should be answered as ‘yes’, and the Form 3501 should be completed to report all pregnancy information.

Example 2. Recipient or recipient’s female partner becomes pregnant at day +68 and had received a commercially available CAR-T product (e.g. Yescarta®). Per protocol, the pregnancy should be reported at the time of knowledge of the pregnancy. The Form 3501 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. When the 100-day Cellular Therapy Essential Data Follow-Up (4100) form is completed, question 180 or 181 should be answered as ‘previously reported’.

Example 3. Recipient or recipient’s female partner becomes pregnant at 1 year and 1 month and had received a commercially available CAR-T product (e.g. Yescarta®). Per protocol, the pregnancy should be reported at the time of knowledge of the pregnancy. The Form 3501 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. The outcome of the first pregnancy does not go to term or does not result in a live birth and another pregnancy event occurs at 1 year and 11 months. It is decided to report the 2nd pregnancy event on the 2 year Cellular Therapy Essential Data Follow-Up (4100) form since it is due. Question 180 or 181 should be answered as ‘yes’ to create another Form 3501.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
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Last modified: Jan 22, 2021

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