Pending Review (8)
Active Cases (23)
Signal Detection (3)
CAPA (5)
| Case ID | Product | Event | Severity | Received Date | Status |
|---|---|---|---|---|---|
| AE-2024-1247 | Study Drug A | Anaphylaxis | Serious | 2024-11-01 | Pending Review |
| AE-2024-1246 | Device XR-200 | Local Reaction | Moderate | 2024-10-30 | Under Investigation |
| AE-2024-1245 | Study Drug B | Elevated Liver Enzymes | Moderate | 2024-10-28 | Awaiting Data |
| AE-2024-1244 | Study Drug A | Nausea | Mild | 2024-10-27 | Pending Review |
| AE-2024-1243 | Device XR-200 | Equipment Malfunction | Moderate | 2024-10-25 | Technical Review |
Active cases under investigation and follow-up...
⚠️ Signal Detected: Potential increase in hepatic events for Study Drug B. Requires immediate review.
🔴 Critical Signal: Multiple reports of anaphylaxis with Study Drug A in Asian populations.
| CAPA ID | Issue | Action Required | Due Date | Status |
|---|---|---|---|---|
| CAPA-2024-089 | Delayed Reporting | Process Improvement | 2024-11-15 | In Progress |
| CAPA-2024-088 | Missing Follow-up Data | Training Required | 2024-11-10 | Scheduled |