Table 5.
Risk of bias assessment per randomised controlled trial (abarelix)
| 149-98-02 | 149-98-03 | 149-99-03 | ABACS1 | |
|---|---|---|---|---|
| Random sequence generation | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) |
| Allocation concealment | Low risk* | Low risk* | Low risk* | Unclear risk (NR) |
| Blinding of participants and personnel: mortality, PSA progression | Low risk† | Low risk† | Unclear risk (NR) | Unclear risk (NR) |
| Blinding of participants and personnel: adverse events, treatment failure, quality of life | High risk‡ | High risk‡ | High risk‡ | High risk‡ |
| Blinding of outcome assessment: mortality, PSA progression | Low risk† | Low risk† | Unclear risk (NR) | Unclear risk (NR) |
| Blinding of outcome assessment: adverse events, treatment failure, quality of life | High risk‡ | High risk‡ | High risk‡ | High risk‡ |
| Incomplete outcome data: mortality, PSA progression | Low risk§ | Low risk§ | Unclear risk (NR) | Unclear risk (NR) |
| Incomplete outcome data: adverse events, treatment failure, quality of life | Low risk§ | Low risk§¶ | Unclear risk (NR) | Unclear risk (NR) |
| Selective reporting | Low risk** | Low risk** | Unclear risk†† | High risk‡‡ |
*Central allocation.
†Open-label study but personnel were unaware of blood values.
‡Open-label study but results are likely to be influenced by lack of blinding.
§Proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate.
¶Missing outcome data balanced in numbers across intervention groups.
**The study protocol is not available but it is clear that the published reports include all expected outcomes.
††No protocol available.
‡‡Adverse events are reported incompletely or study report fails to include results for this outcome.
NR, not reported; PSA, prostate-specific antigen.