Treatment emergent adverse events that occurred in two or more participants
| Sodium selenate OLE | Sodium selenate RCT* (treatment arm) | Sodium selenate phase 1 open label† | |
| Total TEAEs | 24 (86%) 87 | 19 (95%) | Not reported |
| Solicited AEs | 19 (68%) 29 | 14 (70%) 53 | |
| Nail changes | 9 (32%) 10 | 2 (10%) 3 | 5 (26%) |
| Hair loss | 6 (21%) 6 | Nil | 8 (42%) |
| Fatigue | 4 (14%) 4 | 7 (35%) 7 | 9 (47%) |
| Lethargy | 3 (11%) 3 | 6 (30%) 6 | 5 (26%) |
| Vomiting | 2 (7%) 2 | Nil | 4 (21%) |
| Headache | 2 (7%) 2 | 7 (35%) 7 | 3 (16%) |
| Dizziness | 2 (7%) 2 | 4 (20%) 4 | 4 (21%) |
| Unsolicited AEs | 24 (86%) 58 | 7 (35%) 12 | |
| Arthralgia | 4 (14%) 4 | 2 (10%) 2 | 2 (10%) |
| Cold | 4 (14%) 4 | Nil | Not reported |
| Fall | 2 (7%) 4 | Nil | Not reported |
| UTI | 2 (7%) 3 | Nil | Not reported |
| Hypertension | 2 (7%) 2 | Nil | Not reported |
| Back pain | 2 (7%) 2 | Nil | Not reported |
| Influenza | 2 (7%) 2 | Nil | Not reported |
| Constipation | 2 (7%) 2 | Nil | 4 (21%) |
Data are presented as number of participants (percentage of total cohort) total number of events. For comparison, the frequency of adverse events in the treatment group in the randomised controlled trial is also reported,13 and the phase 1 open-label study in prostate cancer.15 Adverse events that occurred in fewer than two participants are not listed.
*Treatment period 24 weeks, n=20.13
†Treatment period 12 weeks, n=19, doses ranged from 5 mg daily to 30 mg three times a day, n=12 on a treatment dose >30 mg/day. Only adverse events at least possibly related to treatment reported.15
AE, adverse event; OLE, open-label extension; RCT, randomised controlled trial; TEAE, treatment emergent adverse event; UTI, urinary tract infection.