本文发表在 rolia.net 枫下论坛6.3.3.2.3. Deaths in Study C4591001 Phase 2/3
There were 6 participants, all in Phase 3, who died through the data cutoff date of 14 November
2020. This included 2 participants in the BNT162b2 group and 4 participants in the placebo
group. None of these deaths were assessed by the investigator as related to study intervention.
Details of the 6 reported deaths among all enrolled participants include:
• One participant in the older BNT162b2 group experienced an SAE of arteriosclerosis and
died 3 days after Dose 1.
• One participant in the older BNT162b2 group experienced an SAE of cardiac arrest 60 days
after Dose 2 and died 3 days later.
• One participant in the younger placebo group experienced an SAE of unevaluable event
(unknown of unknown origin; no additional information currently available at the time of this
report) 8 days after Dose 1 and died the same day.
• One participant in the older placebo group experienced an SAE of hemorrhagic stroke
15 days after Dose 2 and died the next day.
• One participant in the younger placebo group experienced an SAE of death (cause unknown;
no additional information currently available at the time of this report) 34 days after Dose 2.
• One participant in the older placebo group experienced an SAE of myocardial infarction 16
days after Dose 1 and died the same day.更多精彩文章及讨论,请光临枫下论坛 rolia.net
There were 6 participants, all in Phase 3, who died through the data cutoff date of 14 November
2020. This included 2 participants in the BNT162b2 group and 4 participants in the placebo
group. None of these deaths were assessed by the investigator as related to study intervention.
Details of the 6 reported deaths among all enrolled participants include:
• One participant in the older BNT162b2 group experienced an SAE of arteriosclerosis and
died 3 days after Dose 1.
• One participant in the older BNT162b2 group experienced an SAE of cardiac arrest 60 days
after Dose 2 and died 3 days later.
• One participant in the younger placebo group experienced an SAE of unevaluable event
(unknown of unknown origin; no additional information currently available at the time of this
report) 8 days after Dose 1 and died the same day.
• One participant in the older placebo group experienced an SAE of hemorrhagic stroke
15 days after Dose 2 and died the next day.
• One participant in the younger placebo group experienced an SAE of death (cause unknown;
no additional information currently available at the time of this report) 34 days after Dose 2.
• One participant in the older placebo group experienced an SAE of myocardial infarction 16
days after Dose 1 and died the same day.更多精彩文章及讨论,请光临枫下论坛 rolia.net