Table IV.
Adverse events of interest by maximum severity at 24‐month follow‐up.
| AEI, n (%) | Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|---|---|
| Any | 123 (100) | 7 (5·7) | 41 (33·3) | 51 (41·5) | 20 (16·3) | 4 (3·3) |
| Bruising* | 68 (55·3) | 60 (48·8) | 7 (5·7) | 1 (0·8) | 0 | 0 |
| Minor bleeding† | 47 (38·2) | 41 (33·3) | 6 (4·9) | 0 | 0 | 0 |
| Diarrhoea | 44 (35·8) | 29 (23·6) | 14 (11·4) | 1 (0·8) | 0 | 0 |
| Headache | 33 (26·8) | 24 (19·5) | 9 (7·3) | 0 | 0 | 0 |
| SPM | 32 (26·0) | 4 (3·3) | 14 (11·4) | 12 (9·8) | 1 (0·8) | 1 (0·8) |
| Fatigue | 28 (22·8) | 20 (16·3) | 7 (5·7) | 1 (0·8) | 0 | 0 |
| Neutropenia‡ | 28 (22·8) | 1 (0·8) | 4 (3·3) | 7 (5·7) | 16 (13·0) | 0 |
| Arthralgia | 27 (22·0) | 13 (10·6) | 11 (8·9) | 3 (2·4) | 0 | 0 |
| Nausea | 26 (21·1) | 15 (12·2) | 11 (8·9) | 0 | 0 | 0 |
| Hypertension | 24 (19·5) | 1 (0·8) | 12 (9·8) | 11 (8·9) | 0 | 0 |
| Thrombocytopenia§ | 14 (11·4) | 5 (4·1) | 5 (4·1) | 4 (3·3) | 0 | 0 |
| Anaemia | 14 (11·4) | 2 (1·6) | 4 (3·3) | 7 (5·7) | 1 (0·8) | 0 |
| Myalgia | 12 (9·8) | 10 (8·1) | 1 (0·8) | 1 (0·8) | 0 | 0 |
| Petechiae | 10 (8·1) | 9 (7·3) | 1 (0·8) | 0 | 0 | 0 |
| Opportunistic infections | 9 (7·3) | 0 | 3 (2·4) | 3 (2·4) | 3 (2·4) | 0 |
| Atrial fibrillation/flutter | 6 (4·9) | 0 | 2 (1·6) | 4 (3·3)¶ | 0 | 0 |
| Major bleeding# | 4 (3·3) | 0 | 0 | 3 (2·4) | 0 | 1 (0·8) |
AEI, adverse event of interest; SPM, second primary malignancy.
*
Purpura, contusion, or ecchymosis.
†
Pooled term of bleeding, not including bruising, petechiae, or major bleeding.
‡
Neutropenia, neutrophil count decreased, or febrile neutropenia.
§
Thrombocytopenia or platelet count decreased.
¶
Three atrial fibrillation and one atrial flutter.
#
Grade ≥3 haemorrhage.