Please complete this form to report Safety Event(s) and/or Product Quality Complaints to Geron

This electronic form is available to report any of the following:

A safety event that occurred during or after treatment with Rytelo (imetelstat) which may include:
- An adverse event or adverse drug reaction (i.e. side effect)
- Other special situation events (i.e. pregnancy, exposure to Rytelo during breastfeeding, overdose, suspected abuse/misuse, inadvertent or accidental exposure, medication error, or lack of effect).
A Product Quality Complaint (PQC)
- Any possible failure of a drug product to meet any of its specifications.
  - Any written, electronic or oral (or other) communication that alleges deficiencies related to the packaging, labeling, shipping, handling, distribution or other identified non-patient* facing deficiency
  -  or the identity, quality, durability, reliability, safety, effectiveness or performance of the product that may have adverse patient impact that are patient facing* and typically identified PRIOR to treatment.

Note: If the patient experiencing the safety event is participating in an active Geron imetelstat clinical trial, please contact your investigative site to report the safety event or PQC.

For General information about Geron, please click here.

Your data will not be shared with unauthorized 3rd parties.

Fields marked like this * are required to submit a report. Data entry can be performed either by typing or by voice entry by clicking on the microphone icon.

Report Information

Report type (Safety Event/PQC/Both)^*

Geron Reporter

Are you a Geron employee or agent of Geron? (Yes/No)^*

Reporter

Primary Reporter

Sal.

First Name

Last Name

Reporter Qualification^*

Address Line 1

City

State/Province

Postal Code

Country

Reporter confirms Geron or designee may contact them for additional information regarding this report? (Yes/No)^*

HCP?

Additional Contact Details

Initial notification received from primary reporter? (Yes/No)

Was a corresponding AE report filed? (Yes/No)

Patient

Patient Initials

Patient ID for Vendor Program, if applicable

Patient age or patient age group (when event occurred)^*

Patient Age In Years ^*

Patient Age Group^*

Sex at birth

Date of Birth

Safety Event(s)

Safety event term (diagnosis or signs/symptoms)^*

Start Date

Ended or Ongoing

If ended, please provide the date

Relationship to Rytelo

Case Summary

Please provide a summary of the events^*

Product(s)

Product Indication / Type

Product Name^*

Product Indication / Coded Indication

Dose

Unit

NDC #

Dosage Regimens - Batch/Lot # ^* (Enter "unknown" if not available)

Expiry Date

Frequency

Route

What was the first date of dose?

End Date

Discontinuation Date (if applicable)

Medical History

Lab Test

Please complete this form to report Safety Event(s) and/or Product Quality Complaints to Geron

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Mandatory Data Missing/Data Correction

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