Table 2.
Number of patients with treatment-emergent adverse events in ≥10% of participants, by population and by attribution (possible or probable causality)
| Treatment-emergent adverse event | ITT population (n = 50) |
PP population (n = 42) |
TEAEs attributed to 32P device or implantation procedure (PP population; n = 42) |
TEAEs attributed to chemotherapy (PP population; n = 42) |
||||
|---|---|---|---|---|---|---|---|---|
| All grade n (%) | Grade ≥3 n (%) | All grade n (%) | Grade ≥3 n (%) | All grade n (%) | Grade ≥3 n (%) | All grade n (%) | Grade ≥3 n (%) | |
| Total events, n | 1102 | 167 | 956 | 139 | 41 | 8 | 609 | 67 |
| Total participants with ≥1 TEAE | 50 (100.0) | 41 (82.0) | 42 (100.0) | 34 (81.0) | 16 (38.1) | 3 (7.1) | 42 (100.0) | 28 (66.7) |
| Fatigue | 41 (82.0) | 7 (14.0) | 35 (83.3) | 6 (14.3) | 5 (11.9) | 1 (2.4) | 34 (81.0) | 5 (11.9) |
| Nausea | 30 (60.0) | 5 (10.0) | 25 (59.5) | 3 (7.1) | 3 (7.1) | — | 23 (54.8) | 2 (4.8) |
| Diarrhoea | 29 (58.0) | 1 (2.0) | 26 (61.9) | 1 (2.4) | — | — | 21 (50.0) | 1 (2.4) |
| Neutropeniaa | 28 (56.0) | 24 (48.0) | 22 (52.4) | 18 (42.9) | 2 (4.8) | 1 (2.4) | 20 (47.6) | 16 (38.1) |
| Abdominal paina | 26 (52.0) | 6 (12.0) | 22 (52.4) | 5 (11.9) | 3 (7.1) | 1 (2.4) | 5 (11.9) | 1 (2.4) |
| Constipation | 24 (48.0) | 1 (2.0) | 19 (45.2) | 1 (2.4) | — | — | 10 (23.8) | — |
| Alopecia | 21 (42.0) | — | 16 (38.1) | — | — | — | 16 (38.1) | — |
| Decreased appetite | 18 (36.0) | 1 (2.0) | 18 (42.9) | 1 (2.4) | — | — | 16 (38.1) | — |
| Vomiting | 18 (36.0) | 4 (8.0) | 14 (33.3) | 3 (7.1) | — | — | 10 (23.8) | 1 (2.4) |
| Pyrexia | 17 (34.0) | 3 (6.0) | 16 (38.1) | 3 (7.1) | — | — | 11 (26.2) | 2 (4.8) |
| Peripheral neuropathya | 17 (34.0) | 1 (2.0) | 15 (35.7) | 1 (2.4) | — | — | 15 (35.7) | 1 (2.4) |
| Thrombocytopeniaa | 17 (34.0) | 5 (10.0) | 14 (33.3) | 4 (9.5) | 1 (2.4) | 1 (2.4) | 13 (31.0) | 3 (7.1) |
| Anaemiaa | 15 (30.0) | 7 (14.0) | 14 (33.3) | 7 (16.7) | 1 (2.4) | — | 12 (28.6) | 5 (11.9) |
| Weight decreased | 15 (30.0) | 2 (4.0) | 13 (31.0) | 2 (4.8) | 1 (2.4) | — | 10 (23.8) | 1 (2.4) |
| Rash | 13 (26.0) | — | 12 (28.6) | — | — | — | 12 (28.6) | — |
| Peripheral oedemaa | 13 (26.0) | 1 (2.0) | 10 (23.8) | — | — | — | 8 (19.0) | — |
| Hypokalaemiaa | 10 (20.0) | 3 (6.0) | 8 (19.0) | 2 (4.8) | 1 (2.4) | 1 (2.4) | 4 (9.5) | 1 (2.4) |
| Dysgeusia | 8 (16.0) | — | 7 (16.7) | — | — | — | 7 (16.7) | — |
| Hypotension | 8 (16.0) | — | 7 (16.7) | — | 1 (2.4) | — | 1 (2.4) | — |
| Dyspnoea | 8 (16.0) | — | 7 (16.7) | — | — | — | 2 (4.8) | — |
| Pain | 8 (16.0) | 1 (2.0) | 5 (11.9) | 1 (2.4) | — | — | 1 (2.4) | — |
| Pruritus | 7 (14.0) | — | 7 (16.7) | — | — | — | 5 (11.9) | — |
| Pulmonary embolism | 7 (14.0) | 6 (12.0) | 6 (14.3) | 5 (11.9) | 1 (2.4) | 1 (2.4) | 3 (7.1) | 1 (2.4) |
| Mucosal inflammation | 7 (14.0) | 1 (2.0) | 6 (14.3) | 1 (2.4) | — | — | 6 (14.3) | 1 (2.4) |
| Cellulitis | 6 (12.0) | 1 (2.0) | 6 (14.3) | 1 (2.4) | — | — | 4 (9.5) | — |
| Back pain | 6 (12.0) | 1 (2.0) | 6 (14.3) | 1 (2.4) | — | — | — | — |
| Paraesthesia | 6 (12.0) | — | 6 (14.3) | — | — | — | 4 (9.5) | — |
| Hypomagnesemia | 6 (12.0) | — | 5 (11.9) | — | — | — | 4 (9.5) | — |
| Ascites | 6 (12.0) | 2 (4.0) | 4 (9.5) | 2 (4.8) | — | — | 1 (2.4) | 1 (2.4) |
| Device occlusion (stent) | 5 (10.0) | 3 (6.0) | 5 (11.9) | 3 (7.1) | — | — | — | — |
| Epistaxis | 5 (10.0) | 1 (2.0) | 5 (11.9) | 1 (2.4) | — | — | 4 (9.5) | — |
| Oral candidiasis | 5 (10.0) | — | 5 (11.9) | — | — | — | 4 (9.5) | — |
| Hypoalbuminemia | 5 (10.0) | 4 (8.0) | 4 (9.5) | 3 (7.1) | 1 (2.4) | 1 (2.4) | 3 (7.1) | 2 (4.8) |
| Dry mouth | 5 (10.0) | — | 4 (9.5) | — | — | — | 4 (9.5) | — |
| Dizziness | 5 (10.0) | — | 4 (9.5) | — | — | — | 1 (2.4) | — |
TEAEs in ≥10% of study participants at any grade (ITT or PP population). Multiple records from the same study participants are only counted once within the same category.
ITT, intention-to-treat; PP, per protocol (enrolled and implanted participants); TEAE, treatment-emergent adverse event; —, no TEAEs.
Combined records: abdominal pain includes TEAEs reported as abdominal pain irrespective of abdominal site of pain (lower, upper, or not otherwise specified); peripheral oedema includes TEAEs reported as oedema peripheral and/or peripheral swelling; neutropenia includes TEAEs reported as neutropenia, febrile neutropenia, neutropenic sepsis, and/or neutrophil count decreased; thrombocytopenia includes TEAEs reported as thrombocytopenia and/or platelet count decreased; anaemia includes TEAEs reported as anaemia and/or haemoglobin decreased; hypokalaemia includes TEAEs reported as hypokalaemia and/or blood potassium decreased; peripheral neuropathy includes TEAEs reported as peripheral neuropathy and/or peripheral sensory neuropathy.