Table 4.
Risk of bias assessment per randomised controlled trial (degarelix)
| CS21 | CS28 | CS30 | CS31 | CS35 | CS37 | |
|---|---|---|---|---|---|---|
| Random sequence generation | Low risk* | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) |
| Allocation concealment | Low risk† | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) |
| Blinding of participants and personnel: mortality, PSA progression | Low risk‡ | Unclear risk (NR) | Low risk‡ | Unclear risk (NR) | 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§ | High risk§ | High risk§ |
| Blinding of outcome assessment: Mortality, PSA progression | Low risk‡ | Unclear risk (NR) | Low risk‡ | Unclear risk (NR) | 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§ | High risk§ | High risk§ |
| Incomplete outcome data: mortality, PSA progression | Low risk¶ | Unclear risk (NR) | Low risk¶ | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) |
| Incomplete outcome data: adverse events, treatment failure, quality of life | Low risk¶ | Unclear risk (NR) | Low risk¶ | Unclear risk (NR) | Unclear risk (NR) | Unclear risk (NR) |
| Selective reporting | Low risk** | High risk†† | Low risk** | Low risk** | High risk†† | High risk†† |
*Random number generator (computer programme).
†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.
¶Missing outcome data balanced in numbers across intervention groups.
**The study protocol is available and all outcomes that are of interest have been reported.
††Adverse events are reported incompletely or study report fails to include results for this outcome.
NR, not reported; PSA, prostate-specific antigen.