Table 2.
SAEs in Peripheral Blood Apheresis Donors
| Age (yr) | Gender | Race | BMI (Category) | NMDP URD Comorbid Condition Group. | Donation no. | Timing of SAE(d)* | GCSF dose/day (μg/kg) | GCSF (days) | Cumulative Apheresis Blood Volume (L) | Apheresis Duration (d) | CVAD | Expected? | Related? | SAE Description and CTCAE Grade |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 69 | M | W | 32.5 (Obese) | CV: Defer | 1st | 2 | 12.2 | 5 | 60 | 3 | Yes | Yes | Definite | Thrombocytopenia. Hospitalized. Recovered. CTCAE 3 |
| 54 | F | W | 40.3 (Obese) | CV: Accept/Defer unknown† | 1st | −1 | 7.1 | 3 | 30 | 1 | No | No | Probable | Pneumonitis. Possibly due to GCSF.
Recovered. CTCAE 3. |
| 57 | M | W | 26.5 (Overweight) | CV: Accept | 1st | 0 | 10.5 | 5 | 23.1 | 2 | No | Yes | Probable | Vasovagal syncope with hypotension and
bradycardia. Recovered after IV fluids. CTCAE 4. |
| 34 | F | API | 23.2 (Normal) | Hemorrhage requiring medical attention: GI: Accept | 2nd | −3 | 10.72 | 6 | 24.5 | 2 | Yes | No | Possible | Upper GI bleed. Gastric ulcer documented by
EGD. History of prior GI bleed. Recovered. CTCAE 4 |
| 52 | F | W | 28.1 (Overweight) | CNS/Psych: Defer | 1st | 11 | 18.1 | 5 | 24 | 2 | Yes | No | Probable | Hospitalized for observation of liver test
abnormalities and elevated WBC. Recovered. CTCAE Unknown. |
| 41 | F | W | 49.9 (Obese) | CV; Psych: Accept/Defer unknown† | 1st | 0 | 8.1 | 6 | 30 | 2 | Yes | No | Probable | Supraventricular tachycardia during
apheresis. Hospitalization for heart rate control. Prior history of tachycardia Recovered. CTCAE 4 |
| 63 | M | W | 32.3 (Obese) | None: Accept | 1st | 2 | 10 | 6 | 15 | 1 | No | No | Possible | Orthopnea and hypoxemia 2 days after
collection. CT chest. EKG without significant findings. Orthopnea resolved on day 3 post collection. CTCAE 3 |
API indicates Asian/Pacific Islander; CVAD, central venous access device; WBC, white blood cell count; CT, computed tomography.
*
Days before or after initiation of hematopoietic cell collection.
†
Based on NMDP unrelated donor guidelines, more information would be needed to determine whether to accept or defer.