The purpose of this section is to capture any impairments or disorders present during the current reporting period, regardless of treatment or intervention, unless otherwise specified. Review each impairment or disorder description to determine whether treatment or intervention is required for reporting the condition.
Questions 134 – 135: Was gonadal dysfunction requiring hormone replacement present? (testosterone or estrogen)
Gonadal dysfunction requiring hormone replacement affects both males and females. Males experience decreased spermatogenesis and females may experience early symptoms of menopause, including amenorrhea. Low levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and / or testosterone may require hormone replacement therapy.
Indicate if gonadal dysfunction requiring hormone replacement was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with gonadal dysfunction requiring hormone replacement in the reporting period.
If gonadal dysfunction requiring hormone replacement Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
Do not report a recurrence of gonadal dysfunction requiring hormone replacement. Only the first occurrence is captured.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- For transplant, if gonadal dysfunction requiring hormone replacement was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if gonadal dysfunction requiring hormone replacement was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period.
When this is diagnosed post-infusion, do not report gonadal dysfunction requiring hormone replacement if it continued from a previous reporting period into the current reporting period, even if it was present.
If gonadal dysfunction requiring hormone replacement was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present.
Questions 136 – 137: Was hemorrhagic cystitis / hematuria requiring medical intervention present? (catheterization of bladder, extra transfusions, urology consult)
Hemorrhagic cystitis / hematuria is characterized by bleeding and inflammation of the bladder wall. Hemorrhagic cystitis may result from systemic chemotherapy or radiation therapy and / or some viral infections (e.g., BK virus).
Indicate if hemorrhagic cystitis / hematuria requiring medical intervention (i.e., catheterization of bladder, extra transfusions, urology consultation) was present in the current reporting period. Report cases with macroscopic (visible to the naked eye) or grow hematuria (WHO Grade III and IV hemorrhagic cystitis). If the etiology is infectious, also report the infection on the appropriate follow-up form.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with hemorrhagic cystitis / hematuria requiring medical intervention in the reporting period.
- Hemorrhagic cystitis / hematuria requiring medical intervention resolved in a prior reporting period and then recurred in the current reporting period.
If hemorrhagic cystitis / hematuria requiring medical intervention Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- Hemorrhagic cystitis / hematuria requiring medical intervention was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Hemorrhagic cystitis / hematuria requiring medical intervention was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If hemorrhagic cystitis / hematuria requiring medical intervention was not present in the current reporting period or unknown if present, select Not present.
Questions 138 – 139: Did hemorrhagic cystitis / hematuria requiring medical intervention resolve?
Indicate if hemorrhagic cystitis / hematuria requiring medical intervention resolved during the reporting period. If Yes, report the resolution date. The resolution date is the date when the notes specify the condition as resolved and / or medications to treat the condition were completed.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| Q134 – 135 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Gonadal dysfunction requiring hormone replacement affects both males and females. Males experience decreased spermatogenesis and females may experience early symptoms of menopause, including amenorrhea. Low levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and / or testosterone may require hormone replacement therapy. Indicate if gonadal dysfunction requiring hormone replacement was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If gonadal dysfunction requiring hormone replacement was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present. | Added for clarification |
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