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PDX - Adverse Events

Intro page

Form Title: GE Healthcare Pharmaceutical Diagnostics Online Adverse Event Intake Form

The collection, storage, processing and worldwide reporting of personal data connected to adverse events is required by international drug safety regulations. During this process, personal data is protected in accordance to the General Data Protection Regulations GDPR, REGULATION (EU) 2016/679 or other international legislation. As an additional precaution, certain personal data is made anonymous in, or withheld from, individual reports of safety data.

(* Indicates mandatory fields)

2. Is this an initial report (first time you are reporting this issue to GEHC) or a follow-up report (you have reported this issue before to GEHC and want to provide additional details)

3. Who is completing this form? *This question is required.

Please enter an 'other' value for this selection.

4. Please provide any reference number you have for the initial report of this case.

GEHC Global or Local PV reference number Please enter an 'other' value for this selection.
Health Authority reference number Please enter an 'other' value for this selection.
Other reference number Please enter an 'other' value for this selection.

GEHC Representative Details
Indicate what is known about the Reporter, leave field(s) blank where information is not available.

4. GEHC Representative Name

4. Company name

4. Please enter Local Case Number (To be completed by Local Safety Unit (PV Team) – if applicable)

4. GEHC Representative Email *This question is required. This question requires a valid email address.

4. Date where the first person representing GEHC was made aware of the Adverse Event by the original reporter (DD/MMM/YYYY) *This question is required.

4. Who is the original reporter? (Original reporter is the first person that notified a GEHC representative about this report.)

4. Original Reporter agrees to be contacted for follow-up if further information is required. *This question is required.

Please complete this digital Form with all known details and it will be sent to Drug Safety.

Original Reporter Details
Indicate what is known about the Original Reporter, leave field(s) blank where information is not available.

4. Reporter name

4. Telephone

4. Original Reporter's Email *This question is required. This question requires a valid email address.

4. Institution Name (Please provide if applicable)

5. City

6. State (Please provide if applicable)

Reporter Details
Indicate what is known about the Original Reporter, leave field(s) blank where information is not available.

7. Reporter Name

7. Telephone (+91 XXXXX XXXXX)

7. Reporter's Email *This question is required. This question requires a valid email address.

7. Institution Name (Please provide if applicable)

7. City

7. State

Patient Information
Please provide all known information.

7. Patient Initials (First then Last, Enter initials only to protect confidentiality of the patient.)

8. Gender

Please enter an 'other' value for this selection.

9. Pregnant

9. Weight

Please enter an 'other' value for this selection.
Please enter an 'other' value for this selection.

10. Height

Please enter an 'other' value for this selection.
Please enter an 'other' value for this selection.

11. Date of Birth (DD/MMM/YYYY)

12. Age (In Years as in numbers; and any other units if patient is less than 1 year old. Check instructions if needed.)

13. Age Group (if age unknown)

Adverse Event/ Product Complaint Information
Indicate what is known about the Adverse Events.

14. Adverse Event Term *This question is required.

15. Adverse Event start date (DD/MMM/YYYY)

16. Adverse Event stop date (DD/MMM/YYYY)

17. Latency (Describe how long after the start of suspect product administration did the symptoms begin (e.g. 2 hours after suspect product administration started, 1 minute after suspect product administration started)).

18. Duration of Adverse Event (How long did the Adverse Event last?)

19. Adverse Event Outcome (Please pick the most appropriate one.)

20. Seriousness Criteria

Serious Event - Death
Serious Event - Life-threatening
Serious Event - Hospitalization
Serious Event - Disability
Serious Event - Medically Significant
Non-Serious

21. Additional Information Regarding Adverse Events

Please provide event and clinical course details, including diagnosis (if known), symptoms, vital signs/ test results. Please document any medications taken in the two weeks preceding the adverse event, as well as any medication taken for treatment of the adverse event. If the patient has died, please provide the cause of death and autopsy details.

22. Do you want to report additional adverse event(s) for the same patient? *This question is required.

23. Adverse Event Term *This question is required.

23. Adverse Event start date (DD/MMM/YYYY)

23. Adverse Event stop date (DD/MMM/YYYY)

23. Latency (Describe how long after the start of suspect product administration did the symptoms begin (e.g. 2 hours after suspect product administration started, 1 minute after suspect product administration started)).

23. Duration of Adverse Event (How long did the Adverse Event last?)

23. Adverse Event Outcome (Please pick the most appropriate one.)

23. Seriousness Criteria

Serious Event - Death
Serious Event - Life-threatening
Serious Event - Hospitalization
Serious Event - Disability
Serious Event - Medically Significant
Non-Serious

23. Do you want to report additional adverse event(s) for the same patient? *This question is required.

24. Adverse Event Term *This question is required.

24. Adverse Event start date (DD/MMM/YYYY)

24. Adverse Event stop date (DD/MMM/YYYY)

24. Latency (Describe how long after the start of suspect product administration did the symptoms begin (e.g. 2 hours after suspect product administration started, 1 minute after suspect product administration started)).

24. Duration of Adverse Event (How long did the Adverse Event last?)

24. Adverse Event Outcome (Please pick the most appropriate one.)

24. Seriousness Criteria

Serious Event - Death
Serious Event - Life-threatening
Serious Event - Hospitalization
Serious Event - Disability
Serious Event - Medically Significant
Non-Serious

24. Do you want to report additional adverse event(s) for the same patient? *This question is required.

24. Adverse Event Term *This question is required.

24. Adverse Event start date (DD/MMM/YYYY)

24. Adverse Event stop date (DD/MMM/YYYY)

24. Duration of Adverse Event (How long did the Adverse Event last?)

24. Adverse Event Outcome (Please pick the most appropriate one.)

24. Seriousness Criteria

Serious Event - Death
Serious Event - Life-threatening
Serious Event - Hospitalization
Serious Event - Disability
Serious Event - Medically Significant
Non-Serious

24. Do you want to report additional adverse event(s) for the same patient? *This question is required.

24. Adverse Event Term *This question is required.

24. Adverse Event start date (DD/MMM/YYYY)

24. Adverse Event stop date (DD/MMM/YYYY)

24. Duration of Adverse Event (How long did the Adverse Event last?)

24. Adverse Event Outcome (Please pick the most appropriate one.)

24. Seriousness Criteria

Serious Event - Death
Serious Event - Life-threatening
Serious Event - Hospitalization
Serious Event - Disability
Serious Event - Medically Significant
Non-Serious

Suspect Drug Information

24. Suspect Product Info (Trade or Generic Name) *This question is required.

25. Route of administration

26. Formulation

Please enter an 'other' value for this selection.

27. Batch No. / Lot No. / RX No.

28. Dose (Units)

29. Frequency

30. Drug start date (DD/MMM/YYYY)

31. Duration of drug administration

32. Exam Type/Procedure and Indication for procedure (if known)

33. Do you want to report another Suspect Product? *This question is required.

34. Suspect Product Info (Trade or Generic Name) *This question is required.

34. Route of administration

34. Formulation

Please enter an 'other' value for this selection.

34. Batch No. / Lot No. / RX No.

34. Dose (Units)

34. Frequency

34. Drug start date (DD/MMM/YYYY)

34. Duration of drug administration

34. Exam Type/Procedure and Indication for procedure (if known)

Medical Conditions / History

34. Condition(s) - please indicate if current or past condition(s).

35. Specified Risk Factors

Space Cell	Yes	No	Unknown
Renal Impairment	Renal Impairment: Yes	Renal Impairment: No	Renal Impairment: Unknown
Asthma	Asthma: Yes	Asthma: No	Asthma: Unknown
Dehydration	Dehydration: Yes	Dehydration: No	Dehydration: Unknown
Allergies	Allergies: Yes	Allergies: No	Allergies: Unknown

Previous Contrast Exposure

36. Has the patient previously been administered a Contrast/Radiopharmaceutical product before?

37. If Yes, did the patient have a reaction to that product? *This question is required.

37. If Yes, specify product and reaction details

37. Reporter agrees to be contacted for follow-up if further information is required

Please be advised that by proceeding to the next page, you will be unable to return for any corrections. Your submission of the information provided to GEHC will be considered final.