Table 3 Frequency of answers by the SAC. Consensus by the majority of the Safety Adjudication Committee (SAC) members (3/5) was required on the first 3 questions, so that 689 events were adjudicated by the panel. Among them, 682 were confirmed as infections and retained for the analysis
Question for adjudication by the SAC | Yes | No | Impossible to determine | Total with consensus |
|---|---|---|---|---|
1. Based on the information provided, do you confirm that this patient had an infection? | 682 (99%) | 0 | 7 (1%) | 689 (100%) |
2. Is this infection common? | 603 (88.4%) | 78 (11.4%) | 1 (0.2%) | 682 (100%) |
3. Is this an opportunistic infection? | 119 (17.4%) | 556 (81.5%) | 7 (1%) | 682 (100%) |
4. Was the treatment appropriate for the infection? | 484 (77.1%) | 4 (0.6%) | 140 (22.3%) | 628 (92%) |
5. Could the event be possibly related to any of the drug(s) taken at the time of the event? | 307 (76.2%) | 70 (17.4%) | 2 (0.5%) | 403* (59%) |