E2B(R3) generation

C.1.3

Type of Report

C.1.4

Date Report Was First Received from Source

C.1.6.1

Are Additional Documents Available

C.1.6.1.r.1

Documents Held by Sender

C.1.7

Does This Case Fulfill the Local Criteria for an Expedited Report?

C.2.r.1.1

Reporter’s Title

C.2.r.1.2

Reporter’s Given Name

C.2.r.1.3

Reporter’s Middle Name

C.2.r.1.4

Reporter’s Family Name

C.2.r.2.1

Reporter’s Organization

C.2.r.2.2

Reporter’s Department

C.2.r.2.3

Reporter’s Street

C.2.r.2.4

Reporter’s City

C.2.r.2.5

Reporter’s State or Province

C.2.r.2.6

Reporter’s Postcode

C.2.r.2.7

Reporter’s Telephone

C.2.r.3

Reporter’s Country Code

C.2.r.4

Qualification

C.2.r.5

Primary Source for Regulatory Purposes

C.4.r.1

Literature Reference(s)

C.5.3

Sponsor Study Number

C.5.4

Study Type Where Reaction(s) / Event(s) Were Observed

D.1

Patient (name or initials)

D.2.1

Date of Birth

D.2.2.1a

Gestation Period When Reaction / Event Was Observed in the Foetus (value)

D.2.2.1b

Gestation Period When Reaction / Event Was Observed in the Foetus (unit)

D.2.3

Patient Age Group (as per reporter)

D.3

Body Weight (kg)

D.4

Height (cm)

D.5

Sex

D.6

Las Menstrual Period Date

D.7.1.r.1a

MedDRA Version for Medical History

D.7.1.r.1b

Medical history (disease / surgical procedure / etc.) (MedDRA code)

D.7.1.r.2

Start Date

D.7.1.r.3

Continuing

D.7.1.r.4

End Date

D.7.1.r.5

Comments

D.7.1.r.6

Family History

D.7.2

Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)

D.7.3

Concomitant Therapies

D.8.r.1

Name of Drug as Reported

D.8.r.4

Start Date

D.8.r.5

End Date

D.8.r.6a

MedDRA Version for Indication

D.8.r.6b

Indication (MedDRA code)

D.8.r.7a

MedDRA Version for Reaction

D.8.r.7b

Reaction (MedDRA code)

D.9.1

Date of Death

D.9.2.r.1a

MedDRA Version for Reported Cause(s) of Death

D.9.2.r.1b

Reported Cause(s) of Death (MedDRA code)

D.9.2.r.2

Reported Cause(s) of Death (free text)

D.9.3

Was Autopsy Done?

D.9.4.r.1a

MedDRA Version for Autopsy-determined Cause(s) of Death

D.9.4.r.2

Autopsy-determined Cause(s) of Death (free text)

D.10.1

Patient Identification

D.10.2.1

Date of Birth of Parent

D.10.2.2a

Age of Parent (number)

D.10.3

Last Menstrual Period Date of Parent

D.10.4

Body Weight (kg) of Parent

D.10.5

Height (cm) of Parent

D.10.6

Sex of Parent

D.10.7.1.r.1a

MedDRA Version for Medical History

D.10.7.1.r.1b

Medical History (disease / surgical procedure/ etc.) (MedDRA code)

D.10.7.1.r.2

Start Date

D.10.7.1.r.3

Continuing

D.10.7.1.r.4

End Date

D.10.7.1.r.5

Comments

D.10.7.2

Text for Relevant Medical History and Concurrent Conditions of Parent

D.10.8.r.1

Name of Drug as Reported

D.10.8.r.4

Start Date

D.10.8.r.5

End Date

D.10.8.r.6a

MedDRA Version for Indication

D.10.8.r.6b

Indication (MedDRA code)

D.10.8.r.7a

MedDRA Version for Reaction

D.10.8.r.7b

Reactions (MedDRA code)

E.i.1.1a

Reaction / Event as Reported by the Primary Source in Native Language

E.i.1.1b

Reaction / Event as Reported by the Primary Source Language

E.i.1.2

Reaction / Event as Reported by the Primary Source for Translation

E.i.2.1a

MedDRA Version for Reaction / Event

E.i.2.1b

Reaction / Event (MedDRA code)

E.i.3.1

Term Highlighted by the Reporter

E.i.3.2a

Results in Death

E.i.3.2b

Life Threatening

E.i.3.2c

Caused / Prolonged Hospitalisation

E.i.3.2d

Disabling / Incapacitating

E.i.3.2e

Congenital Anomaly / Birth Defect

E.i.3.2f

Other Medically Important Condition

E.i.4

Date of Start of Reaction / Event

E.i.5

Date of End of Reaction / Event

E.i.6a

Duration of Reaction / Event (number)

E.i.6b

Duration of Reaction / Event (unit)

E.i.7

Outcome of Reaction / Event at the Time of Last Observation

E.i.8

Medical Confirmation by Healthcare Professional

E.i.9

Identification of the Country Where the Reaction / Event Occurred

F.r.1

Test Date

F.r.2.1

Test Name (Free text)

F.r.2.2a

MedDRA Version for Test Name

F.r.2.2b

Test Name (MedDRA code)

F.r.3.1

Test Result (code)

F.r.3.2

Test Result (value / qualifier)

F.r.3.3

Test Result (unit)

F.r.3.4

Result Unstructured Data (free text)

F.r.4

Normal Low Value

F.r.5

Normal High Value

F.r.6

Comments (free text)

F.r.7

More Information Available

G.k.1

Characterization of Drug Role

G.k.2.2

Medicinal Product Name as Reported by the Primary Source

G.k.2.4

Identification of the Country Where the Drug Was Obtained

G.k.3.1

Authorization / Application Number

G.k.3.2

Country of Authorization / Application

G.k.3.3

Name of Holder / Applicant

G.k.4.r.1a

Dose(number)

G.k.4.r.1b

Dose (unit)

G.k.4.r.2

Number of Units in the Interval

G.k.4.r.3

Definition of the Time Interval Unit

G.k.4.r.4

Date and Time of Start of Drug

G.k.4.r.5

Date and Time of Last Administration

G.k.4.r.6a

Duration of Drug Administration (number)

G.k.4.r.6b

Duration of Drug Administration (unit)

G.k.4.r.7

Batch / Lot Number

G.k.4.r.8

Dosage Text

G.k.4.r.9.1

Pharmaceutical Dose Form (free text)

G.k.4.r.10.1

Route of Administration (free text)

G.k.4.r.10.2a

Route of Administration TermID Version Date / Number

G.k.4.r.10.2b

Route of Administration TermID

G.k.4.r.11.1

Parent Route of Administration (free text)

G.k.4.r.11.2a

Parent Route of Administration TermID Version Date / Number

G.k.4.r.11.2b

Parent Route of Administration TermID

G.k.5a

Cumulative Dose to First Reaction (number)

G.k.5b

Cumulative Dose to First Reaction (unit)

G.k.6a

Gestation Period at Time of Exposure (number)

G.k.6b

Gestation Period at Time of Exposure (unit)

G.k.7.r.1

Indication as Reported by the Primary Source

G.k.7.r.2a

MedDRA Version for Indication

G.k.8

Action(s) Taken with Drug

G.k.9.i.3.1a

Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)

G.k.9.i.3.1b

Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)

G.k.9.i.3.2a

Time Interval between Last Dose of Drug and Start of Reaction / Event (number)

G.k.9.i.3.2b

Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)

G.k.9.i.4

Did Reaction Recur on Re-administration?

G.k.11

Additional Information on Drug (free text)

H.1

Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information

H.2

Reporter’s Comments

N.1.3

Batch Sender Identifier

N.1.4

Batch Receiver Identifier

N.2.r.2

Message Sender Identifier

N.2.r.3

Message Receiver Identifier