Adverse event intake, severity triage and regulatory escalation — auditable to Schedule Y of the New Drugs and Clinical Trials Rules 2019, and CIOMS-I report format.
| AE ID | Patient | Event | Severity | Causality | Reported by | Stage | SLA clock |
|---|---|---|---|---|---|---|---|
| AE-2026-0387 |
VK
Patient #DBS-04127Female, 58 · Mumbai · Tresiba 18u
|
Hypoglycaemia, non-severe Reported via app symptom log · 11 May 14:08 |
Moderate | Probable | Patient + coach Verified by Dr. V. Joshi |
Sponsor handoff | 18h 42m remaining |
| AE-2026-0386 |
RS
Patient #DBS-03914Male, 64 · Chennai · Ryzodeg 26u
|
Injection-site reaction Localised erythema · patient photo attached |
Mild | Possible | Patient (app) Coach verified |
Clinician follow-up | 9h 14m remaining |
| AE-2026-0385 |
PA
Patient #DBS-03801Female, 42 · Pune · Tresiba 14u
|
Nocturnal hypoglycaemia Self-resolved · 3rd episode in 30 days |
Moderate | Probable | Patient (coach call) | Triage | 2h 18m remaining |
| 15-day expedited Serious AE — Schedule Y | 8 | On-time |
| PSUR submissions Q1 2026 filed Apr | 1 | Filed |
| DSUR contribution Annual to sponsor | 1 | Submitted |
| Risk-management update Triggered Apr | 1 | Closed |
| Periodic line listing Monthly to sponsor | 4 | Current |