Table 3 Additional adverse events identified by monitoring
Adverse Event | Arm | Grade | SAE | AESI | Comment |
|---|---|---|---|---|---|
Lymphocyte count decreased | IC14 | 4 | No | No | Lab data were automatically extracted, but no AE ECRF was completed because lymphopenia is a common AE related to severe COVID-19. AE ECRF was subsequently completed at the request of the monitor. AE judged by the investigator to be unrelated to the study drug. |
Activated partial thromboplastin time prolonged | Ciproheptadine | 3 | No | No | No AE ECRF was completed because “elevated aPTT was an intended therapeutic effect of the heparin drip the patient was on.” AE ECRF was completed at the request of the monitor. According to the investigator, this event was “unlikely” to be related to the study drug. |
Thromboembolic event | Control | 3 | Yes | No | The investigator checked the box for PE in the daily report form and additionally noted the occurrence in the free-text section. An additional AE ECRF was not completed at the time, but was requested during retrospective monitoring. |
Lymphocyte count decreased | Control | 3 | No | No | Lab data were automatically extracted, but no AE ECRF was completed because lymphopenia is a common AE related to severe COVID-19. AE ECRF subsequently completed at request of monitor. |
Lymphocyte count decreased | Control | 3 | No | No | See the grade 3 lymphocyte count above. |
Anemia | Control | 3 | No | No | Lab data were automatically extracted but no AE ECRF was completed because anemia is a common AE related to critical illness. AE ECRF completed at request of monitor. |
Seizure | Control | 3 | No | No | An adverse event occurred immediately after consent, prior to the administration of the study drug. The event was known to the sponsor as the patient was moved off the interventional arm. No AE ECRF was initially completed because the patient had not received the study drug. AE ECRF was subsequently completed at the request of the monitor. |
GI Bleeding | Control | 3 | No | No | Bleeding was noted in the daily events free-text form, but no AE ECRF was completed at the time. AE ECRF subsequently completed at the request of monitor. |
GI Bleeding | Cyclosporine | 3 | Yes | No | This AE was not noted in the daily form and no AE was completed. AE ECRF was subsequently completed at the request of monitor. AE judged by the investigator to be unrelated to the study drug. |
Elevated Liver Function Tests | Narsoplimab | 2 | No | Yes | Lab data were automatically extracted, but no AE ECRF was completed. AE ECRF completed at request of monitor. In the opinion of the investigator, the AE was “possibly” related to the study drug. |
Myocardial Infarction | Cyclosporine | 1 | No | No | Not recorded in the daily events report. This event was detected by a CRA query after reviewing the EHR, which resulted in a change of the daily reform and completion of AE ECRF. In the judgment of the investigator and the SWG, this event was related to COVID myocarditis, present upon admission, and was unrelated to the study drug. |
