Table 2.
Adverse events during the extension study by inter-donation interval groups
| Grade* |
Overall |
Men (n=10 843 in extension) |
Women (n=9914 in extension) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | n (%) | 8 weeks | 10 weeks | 12 weeks | 12 weeks | 14 weeks | 16 weeks | |||
| Any self-reported serious adverse events† | ·· | 18 550 | 536 (2·9%) | 75 (2·4%) | 91 (2·8%) | 93 (2·9%) | 82 (2·7%) | 102 (3·5%) | 93 (3·2%) | |
| Doctor diagnosed heart problems | 3 | 18 528 | 69 (0·4%) | 14 (0·4%) | 20 (0·6%) | 17 (0·5%) | 4 (0·1%) | 5 (0·2%) | 9 (0·3%) | |
| Doctor diagnosed heart failure | 3 | 18 528 | 18 (0·1%) | 5 (0·2%) | 4 (0·1%) | 5 (0·2%) | 1 (0·0%) | 1 (0·0%) | 2 (0·1%) | |
| Doctor diagnosed heart attack | 3 | 18 526 | 20 (0·1%) | 7 (0·2%) | 5 (0·2%) | 4 (0·1%) | 1 (0·0%) | 0 (0·0%) | 3 (0·1%) | |
| Doctor diagnosed angina | 3 | 18 526 | 24 (0·1%) | 6 (0·2%) | 6 (0·2%) | 5 (0·2%) | 1 (0·0%) | 4 (0·1%) | 2 (0·1%) | |
| Doctor diagnosed stroke | 3 | 18 527 | 17 (0·1%) | 4 (0·1%) | 7 (0·2%) | 1 (0·0%) | 2 (0·1%) | 1 (0·0%) | 2 (0·1%) | |
| Doctor diagnosed transient ischaemic attack | 3 | 18 527 | 21 (0·1%) | 5 (0·2%) | 5 (0·2%) | 5 (0·2%) | 2 (0·1%) | 1 (0·0%) | 3 (0·1%) | |
| Visit to hospital for a fall | 3 | 18 533 | 337 (1·8%) | 39 (1·2%) | 39 (1·2%) | 47 (1·5%) | 64 (2·1%) | 81 (2·8%) | 67 (2·3%) | |
| Visit to hospital for transport accident | 3 | 18 516 | 150 (0·8%) | 26 (0·8%) | 36 (1·1%) | 36 (1·1%) | 17 (0·6%) | 17 (0·6%) | 18 (0·6%) | |
| Any symptom self-reported | 1–2 | 18 554 | 9732 (52·5%) | 1581 (49·6%) | 1556 (47·1%) | 1476 (45·6%) | 1764 (58·8%) | 1699 (58·0%) | 1656 (57·2%) | |
| Fainting or feeling faint | 1–2 | 18 534 | 2085 (11·3%) | 325 (10·2%) | 302 (9·2%) | 269 (8·3%) | 424 (14·1%) | 390 (13·3%) | 375 (13·0%) | |
| More tired than usual | 1–2 | 18 537 | 5198 (28·0%) | 864 (27·1%) | 823 (24·9%) | 800 (24·8%) | 947 (31·6%) | 881 (30·1%) | 883 (30·5%) | |
| Palpitations | 1–2 | 18 502 | 2217 (12·0%) | 271 (8·5%) | 286 (8·7%) | 261 (8·1%) | 498 (16·6%) | 435 (14·9%) | 466 (16·2%) | |
| Dizziness | 1–2 | 18 533 | 3197 (17·3%) | 457 (14·4%) | 456 (13·8%) | 419 (13·0%) | 657 (21·9%) | 617 (21·1%) | 591 (20·4%) | |
| Restless legs syndrome | 1–2 | 18 464 | 4158 (22·5%) | 642 (20·2%) | 642 (19·5%) | 613 (19·0%) | 776 (26·0%) | 753 (25·8%) | 732 (25·4%) | |
Data presented are n (%) unless otherwise stated. Adverse events listed in this table were ascertained only through self-report questionnaires and mapped to Common Terminology Criteria for Adverse Events grading using heuristic criteria. For adverse events of grade 1–2, only those occurring in 10% or more of patients are reported.
Grading with reference to Common Terminology Criteria for Adverse Events version 5.0.
Number and percentage of participants reporting any serious adverse events during the extension study in any of the 6-monthly questionnaires, including doctor-confirmed heart failure, heart attack, angina, stroke, or transient ischaemic attack; or hospital visit for falls or transport accidents. Study participants could contribute to more than one outcome in this table.