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. 2019 Jul 13;46:423–430. doi: 10.1016/j.ebiom.2019.07.013

Table 2.

Primary outcome. Safety and tolerability was the primary outcome as judged by the occurrence of adverse events and serious adverse events. Data are presented for each treatment group as described in the study protocol. The number of events and percentage of group experiencing the event are listed.

NAC alone
NAC + 2 μmol/kg calmangafodipir
NAC + 5 μmol/kg calmangafodipir
NAC + 10 μmol/kg calmangafodipir
Event (N = 6) (N = 6) (N = 6) (N = 6)
Any adverse event 6 (100%) 6 (100%) 6 (100%) 6 (100%)
Any serious adverse event 2 (33%) 4 (67%) 2 (33%) 3 (50%)
Adverse event starting after commencement of NAC treatment and within 7 days of consent 6 (100%) 5 (83%) 6 (100%) 6 (100%)
Serious adverse event starting after commencement of NAC treatment and within 7 days of consent 1 (17%) 1 (17%) 1 (17%) 2 (33%)
Adverse event unrelated to NAC 3 (50%) 5 (83%) 3 (50%) 5 (83%)
Adverse event possibly related to NAC 2 (33%) 2 (33%) 2 (33%) 2 (33%)
Adverse event probably related to NAC 3 (50%) 2 (33%) 3 (50%) 2 (33%)
Adverse event definitely related to NAC 2 (33%) 3 (50%) 1 (17%) 1 (17%)
Adverse event unrelated to calmangafodipir 6 (100%) 6 (100%) 5 (83%) 6 (100%)
Adverse event possibly related to calmangafodipir 0 (0%) 4 (67%) 2 (33%) 2 (33%)
Adverse event probably related to calmangafodipir 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Adverse event definitely related to calmangafodipir 0 (0%) 0 (0%) 0 (0%) 0 (0%)