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Comply

Safety Management

AE / SAE intake, signal detection, and risk monitoring.

Ask AI Forecast

SAEs requiring reporting

Median triage time

Active safety signals

Adverse events queue

AE	Patient	Trial	Term	Severity	SAE
AE-08421	PT-2041	ONCO-204	Grade 2 Neutropenia	Moderate	—	Investigate
AE-08418	PT-2039	ONCO-204	Grade 3 Hypertension	Severe	—	Investigate
AE-08410	PT-2010	ONCO-307	Pneumonitis	Severe	SAE	Investigate
AE-08402	PT-1998	RD-118	Headache	Mild	—	Investigate

Active safety signals

ONCO-307 — Pneumonitis cluster (3 cases)
Recommendation: Convene DSMB this week
High
ONCO-204 — QT prolongation drift (2 sites)
Recommendation: Add ECG monitoring at C2D1
Med
RD-118 — Liver enzyme elevation outlier
Recommendation: Continue routine monitoring
Low

Reporting clock

All reporting deadlines tracked against FDA, EMA, PMDA, and MHRA timelines automatically.