CASE-AE-26-0089
Suspected hypoglycaemia & nausea · Anjali Kapur
⏱ 9d 14h LEFT · 15-day expedited SERIOUS · MEDICALLY SIGNIFICANT
Case workflow
Owner: Dr. V. Joshi · escalated by Priya R.
Currently at step 3 of 6 · MD review
Detect
Intake
MD review
4
Narrative
5
CIOMS prep
6
Submit
Event detail
Patient's verbatim account
Priya didi, since yesterday I am feeling very dizzy and nauseous after the injection. I had to lie down for almost an hour. Today again the same thing happened after morning dose. Should I stop or continue?
Onset date
11 May 2026 · ~21:30 IST
Episodes so far
3 · ongoing
Duration each episode
~45–60 min
Pattern
post-injection, 30–60 min after
MedDRA PT
Hypoglycaemia, symptomatic · 10020994
Secondary PT
Nausea · 10028813
Suspect drug
Ryzodeg 70/30 · 30 U OD · batch GZX-2618-04
Concomitants
Metformin · Glimepiride · Atorva
⌛ Pending · with Dr. V. Joshi for ~21h · soft SLA 24h, hard SLA 48h
MD action required: confirm causality & clinical narrative
The clinical narrative below will be drafted by Dr. Joshi based on coach report and clinical history. Once the narrative is signed, the case moves to step 4 → CIOMS prep.
VJ
Dr. Vinod Joshi · Endocrinology · Hinduja Mumbai
Last seen on platform: 12 May, 12:42 IST · idle 47 min
Last seen on platform: 12 May, 12:42 IST · idle 47 min
Case audit trail
Timeline · all events on this case
12 MAY08:48 IST
⚠
AE auto-flagged · NLP keyword detector
WhatsApp message from patient contained "dizzy" + "nausea". Severity classifier suggested: SERIOUS (medically significant) based on pattern + duration.
By PV-Auto-Detector v2.4 · routed to coach Priya R.
12 MAY09:08 IST
✎
Coach triage call · 18 min
Priya called patient. Confirmed 3 episodes since 11 May evening. Patient mood: anxious. No third-party intervention required so far but episodes are escalating. Coach advised to stop dose pending MD; case escalated immediately.
By Priya R. · call CALL-PR-26512-04 attached
12 MAY09:12 IST
📋
PV intake form submitted
Initial intake completed by coach. Severity: Moderate; Seriousness: Medically significant; WHO-UMC: Probable/Likely. 15-day expedited path triggered. Dr. Joshi auto-notified.
By Priya R. · intake form attached
12 MAY09:14 IST
⤴
Auto-notify · Dr. Joshi (treating MD)
SMS + in-app push + email sent. Read receipt at 11:04 IST. MD acknowledged but no formal review filed yet.
By System · channel: SMS, app, email
12 MAY09:18 IST
📤
Forwarded to Novo Nordisk safety
Initial case data forwarded to Novo Nordisk India safety inbox via secure API. Acknowledgement received with NN tracking ID: NN-PV-26-IN-2087.
By System · sponsor: Novo Nordisk India safety
12 MAY11:32 IST
📎
Attachment uploaded · coach call recording
Encrypted .wav file + auto-transcript (Hindi + English) attached to case. Available to MD reviewer.
By System · 4.2 MB · 18m 04s
12 MAY12:42 IST
👁
MD viewed case · 3m 18s
Dr. Joshi opened case · viewed intake form, patient history, and coach call transcript. No notes added yet.
By Dr. V. Joshi
12 MAY13:08 IST
↻
Follow-up call scheduled with patient
Coach scheduled f/u call for 14 May 10:00 IST to assess ongoing symptoms & capture any further data for MD review.
By Priya R. · 48h follow-up cadence per SOP
Regulatory submission
15-day expedited path
PathExpedited · serious AE
Clock started12 May 2026, 09:12
Statutory due27 May 2026, 23:59
Internal SLA22 May (5 days earlier)
Time remaining9d 14h 22m
Sponsor ack✓ NN-PV-26-IN-2087
CDSCO submissionpending CIOMS
Reporting jurisdictionIndia · CDSCO & NCC-PvPI
Evidence pack
Attachments (5)
Sponsor safety liaison
Communication log
Novo Nordisk Safety → Diabeasy PV
12 MAY · 09:21
Acknowledged receipt. Assigned tracking ID NN-PV-26-IN-2087. Please share signed clinical narrative once MD review is complete. Reminder: 15-day clock applies.
Diabeasy PV → Novo Nordisk Safety
12 MAY · 09:18
Initial intake forwarded. Suspected hypoglycaemia, symptomatic, with nausea. Coach has paused next dose pending MD direction. Will share narrative within 48h.
Priya R. → Dr. Joshi
12 MAY · 09:14
Dr saab — flagging this case. Patient has had 3 episodes in 14h. I have asked her to hold the next dose. Please advise & sign the clinical review at your earliest. Full intake attached.