Overview
Demo workbenchMorning safety review for the sponsor PV team
Canary brings intake, signal review, case work, RSI expectedness, and E2B reporting into one operating view so the next action is visible before the first meeting of the day.
Handoff health
Cross-app seams feeding today's PV queue.
AE_ESCALATED events opened as Canary cases
post-market FHIR adverse events in PV review
E2B packages awaiting final action
Featured safety thread
One drug-event story from signal artifact to authority package.
Tacrolimus / Posterior reversible encephalopathy syndrome
- EB05
- 4.8
- Observed
- 11
- Grade
- 4
Subject developed seizure and visual disturbance after elevated tacrolimus trough; imaging pattern consistent with PRES. Sponsor assessment remains possible pending repeat level review.
Priority signals
Tacrolimus
Posterior reversible encephalopathy syndrome
Cyclophosphamide
Hemorrhagic cystitis
Fludarabine
Encephalopathy
Cytarabine
Cerebellar syndrome
Sirolimus
Thrombotic microangiopathy
Case worklist
Posterior reversible encephalopathy syndrome
15-day clock: 3d remaining
Haemorrhagic cystitis
15-day clock: 7d remaining
Hepatic veno-occlusive disease
15-day clock: 9d remaining
Electrocardiogram QT prolonged
Follow-up documents pending
Thrombotic microangiopathy
Submitted on day 12
Submission readiness
Draft and ready packages across regulator and partner lanes.
FDA FAERS
CNY-2026-0042 / Initial expedited
EMA EudraVigilance
CNY-2026-0039 / Initial expedited
MHRA Yellow Card
CNY-2026-0037 / Initial expedited