Teva sponsored program adverse event form

Date of awareness of the Adverse Event (or Follow-up date)

For follow-up reports, enter the date when follow-up information was received.

Protocol No. / Project No. / Program Name

Please choose from drop down if available

Other

Please enter the project number

Country Required

Type of Report

Reference Number

Add all available report numbers or case identifiers. If this is a Follow-up add initial report number.

Reference Number 2

Add all available report numbers or case identifiers. If this is a Follow-up add initial report number.

Would you like to add another reference number?

Yes

Reference Number 3

Add all available report numbers or case identifiers. If this is a Follow-up add initial report number.

Patient Information

Patient Initials

Date of Birth

Age (Years)

Age Group Required

Gender Required

If patient is pregnant: Last Menstrual Period Date:

Body Weight

Height

Does Teva have permission to contact the patient about this report?

Yes

Phone

E-mail

No

Does the Service Provider have permission to contact the patient about this report?

Yes

Service Provider Phone

Service Provider E-mail

No

Is the reporter an HCP?

Yes

Reporter

For PSP - complete this section only if the PSP Healthcare Professional witnessed the event and can confirm the AE

Healthcare Professional Last Name or Initials

Healthcare Professional First Name or Initials

Qualification

Phone

E-mail

Street Address

City

State/Province/County

Postal Code

No

Product

Product (Brand name)

Product Type Required

Dose

Unit Dose

Dosage Form

Dose Frequency

Route of administration

Product Start Date

Product Stop Date

Indication

Action taken with drug

Batch/Lot number

This is a mandatory field for biologic products. If the Batch is unknown, please write "unknown".

Was the patient taking additional medication?

Yes

Product

Product Type Required

Is this product a suspect or concomitant?

Dose

Unit Dose

Dosage Form

Dose Frequency

Route of administration

Product Start Date

Product Stop Date

Indication

Action taken with drug

Batch/Lot number

This is a mandatory field for biologic products. If the Batch is unknown, please write "unknown".

No

Was the patient taking additional medication? If additional reporting for medication is required please add to narrative.

Yes

Product

Product Type Required

Is this product a suspect or concomitant?

Dose

Unit Dose

Dosage Form

Dose Frequency

Route of administration

Product Start Date

Product Stop Date

Indication

Action taken with drug

Batch/Lot number

This is a mandatory field for biologic products. If the Batch is unknown, please write "unknown".

No

Adverse Event

Please describe the adverse event(s)

When did the adverse event(s) start?

When did the adverse event(s) end?

Did the adverse event(s) result in any of the following?

If serious, please choose the relevant Seriousness Criteria

Did the patient recover from the adverse event(s)? Required

Reporter's Causality

Would you like to report another Adverse Event?

Yes

Please describe the adverse event(s)

When did the adverse event(s) start?

When did the adverse event(s) end?

Did the adverse event(s) result in any of the following?

If serious, please choose the relevant Seriousness Criteria

Did the patient recover from the adverse event(s)?

Reporter's Causality

No

Case narrative

Please describe as reported

Did the patient die?

Yes

Date of death

Was autopsy performed?

Cause of death?

No

Medical History

Other diagnosed illnesses / medical history / chronic health conditions/ past medication. Please indicate if patient is tobacco smoker or alcohol consumer

Start date of the condition

Is the condition continuing?

End date of the condition

Is there another medical history to report?

Yes

Other diagnosed illnesses / medical history / chronic health conditions

Start date of the condition

Is the condition continuing?

End date of the condition

No

Attach a file here

Consent to the processing of the personal data Required

I confirm that the details I have provided are correct

By clicking the "Submit" button, you confirm your consent to the processing of the personal data as provided in the report. Personal data will be used by Teva Pharmaceutical Industries Ltd. and its affiliates solely to meet our obligations, and may be transferred out of your country.

For more information on how Teva processes your personal data, including information on your data protection rights, please visit our privacy policy.

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