Table 3.
Univariate analysis of skeletal pain and body symptoms experienced by related PBSC adult donors at pre-donation, on the first day of collection prior to apheresis, and at 1 month, 6 months, and 1 year post-donation, by age at donation. (Skeletal pain represents pain in at least one of the following sites: back, bone, headache, hip, joints, limbs, and neck. The severity of skeletal pain is defined as the maximum grade among these pain sites. Body symptoms include fever in absence of infections, fatigue, skin rash, injection site reaction, nausea, vomiting, anorexia, insomnia, dizziness, and syncope. The toxicity level is defined as the maximum grade among these symptoms.)
| Age 18 to 40 | Age 41 to 60 | Age 61 and older | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Event and time point | N | # of events (%) |
95% CIa | N | # of events (%) |
95% CIa | N | # of events (%) |
95% CIa | p-valueb |
| Skeletal pain | ||||||||||
| Pre-donation, grade 2–4 | 261 | 14 ( 5) | (3–9) | 695 | 65 ( 9) | (7–12) | 255 | 23 ( 9) | (6–13) | 0.122 |
| First day of collection, grade 2–4 | 260 | 134 (52) | (45–58) | 690 | 281 (41) | (37–44) | 254 | 78 (31) | (25–37) | <0.001 |
| First day of collection, grade 3–4 | 260 | 52 (20) | (15–25) | 690 | 86 (12) | (10–15) | 254 | 29 (11) | (8–16) | 0.007 |
| At 1 month, grade 2–4 | 207 | 14 ( 7) | (4–11) | 626 | 70 (11) | (9–14) | 244 | 39 (16) | (12–21) | 0.009 |
| At 6 months, grade 2–4 | 200 | 18 ( 9) | (5–14) | 616 | 99 (16) | (13–19) | 243 | 33 (14) | (10–19) | 0.039 |
| At 1 year, grade 2–4 | 191 | 14 ( 7) | (4–12) | 584 | 98 (17) | (14–20) | 234 | 42 (18) | (13–23) | 0.002 |
| Non-recovery at 1 month | 207 | 38 (18) | (13–24) | 626 | 170 (27) | (24–31) | 244 | 77 (32) | (26–38) | 0.005 |
| Non-recovery at 6 months | 200 | 49 (25) | (19–31) | 616 | 176 (29) | (25–32) | 243 | 75 (31) | (25–37) | 0.327 |
| Non-recovery at 1 year | 191 | 49 (26) | (20–32) | 584 | 201 (34) | (31–38) | 234 | 79 (34) | (28–40) | 0.071 |
| Body Symptoms | ||||||||||
| Pre-donation, grade 2–4 | 255 | 13 ( 5) | (3–9) | 678 | 10 ( 1) | (1–3) | 250 | 7 ( 3) | (1–6) | 0.009 |
| First day of collection, grade 2–4 | 260 | 62 (24) | (19–30) | 691 | 110 (16) | (13–19) | 255 | 39 (15) | (11–20) | 0.012 |
| At 1 month, grade 2–4 | 207 | 10 ( 5) | (2–9) | 627 | 40 (6) | (5–9) | 244 | 14 ( 6) | (3–9) | 0.756 |
| At months, grade 2–4 | 200 | 12 ( 6) | (3–10) | 615 | 40 ( 7) | (5–9) | 243 | 11 ( 5) | (2–8) | 0.575 |
| At 1 year, grade 2–4 | 192 | 10 ( 5) | (3–9) | 585 | 38 ( 6) | (5–9) | 235 | 13 ( 6) | (3–9) | 0.813 |
| Non-recovery at 1 month | 202 | 44 (22) | (16–28) | 610 | 125 (20) | (17–24) | 239 | 51 (21) | (16–27) | 0.897 |
| Non-recovery at 6 months | 195 | 39 (20) | (15–26) | 598 | 109 (18) | (15–22) | 239 | 42 (18) | (13–23) | 0.793 |
| Non-recovery at 1 year | 187 | 25 (13) | (9–19) | 569 | 102 (18) | (15–21) | 232 | 34 (15) | (10–20) | 0.271 |
a
Exact confidence interval
b
Fisher’s Exact Test p-value