Q199-200: Pregnancy Status

*Pregnancy Status
This section focuses on fertility. This is an important section due to the possibility of some genetically modified cells persisting and possible transmission to the fetus.

!Pregnancy Questions
Pregnancy questions will only be answered for recipients between the ages of 10 and 60.

*Combined follow up
In scenarios where an HCT was given after a cellular therapy and this form is now being completed based on the subsequent HCT date, new malignancies will always be reported on the Cellular Therapy Essential Data Follow- Up (4100) forms and disabled on the Post-HSCT Data (2100).

Question 199: Was the recipient pregnant at any time in this reporting period? (Female Only)

Indicate whether the recipient was pregnant at any time during the reporting period. Skip this question for male recipients.

If Yes, complete the Pregnancy (3501) form.

The Previously reported option 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). See examples below.

If the pregnancy status is not officially documented, report as Unknown.

Contact CIBMTR Center Support with questions.

Question 200: Was the recipient’s female partner pregnant at any time in this reporting period? (Male only)

Indicate whether the male recipient’s female partner was pregnant at any time during the reporting period. Skip this question for female recipients.

If Yes, complete the Pregnancy (3501) form also.

The Previously reported option 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). See examples below.

If the pregnancy status is not officially documented, report as Unknown.

Contact CIBMTR Center Support with questions.

Reporting Scenarios:

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. These questions 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., Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, Tecelra®, 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^SM and completed in a timely manner. When the 100-day Cellular Therapy Essential Data Follow- Up (4100) form is completed, these questions 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., Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, Tecelra®, 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^SM 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 Post-CTED (4100) form since it is due. These questions should be answered as Yes to create another Form 3501.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
.	.	.	.	.

Copyright © 2004-2025 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.