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Table 3 E2B data elements available in the selected apps

From: Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience

App number

App name

Minimal information category

Identifiable patient

Identifiable reporter

Adverse event/reaction (or outcome)

Suspect or interacting drug

1

ADR Online

Age at time of onset of reaction/Date of birth

Medical historya

Name or initials

Sex

Email address

Qualification

Reporter’s name

Reaction (text input)

Fatality

Date of start of reaction

Outcome of reactions at the time of last observation

Severity

Drug name (text input)

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

2

ADR PvPI

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (text input)

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (text input)

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

3

ADR Reporter

Age at time of onset of reaction/Date of birth

Name or initials

Sex

Email address

Reporter’s name

Reaction (text input)

Drug name (text input)

Dosage

Indication

Route of administration

4

DGDA Drug Verification

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (text input)

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (text input)

Actions taken with drug

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

5

Easypharm

Age at time of onset of reaction/Date of birth

Name or initials

Sex

Reporter’s name

Reaction (text input)

Drug name (text input)

6

ELEA Onco-Biotech

Name or initials

Email address

Reporter’s name

Reaction (list)c

Drug name (list)b

7

HALMED

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (text input)

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (list)

Actions taken with drug

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

8–15

Med Safety

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (list and text input)d

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (list)

Actions taken with drug

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

16

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Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (text input)

Date of start of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (text input)

Actions taken with drug

Dosage

Indication

Route of administration

17

My eReport

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (text input)

Date of start of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (list)

Date of start of drug

Dosage

Route of administration

18

Only available free-text fields were labeled “City” and “Description”

Only available free-text fields were labeled “City” and “Description”

Only available free-text fields were labeled “City” and “Description”

Only available free-text fields were labeled “City” and “Description”

19

SiddAR

Age at time of onset of reaction/Date of birth

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (text input)

Date of start of reaction

Date of end of reaction

Seriousness criteria at event level

Drug name (text input)

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

20

TMDA Adverse Reactions Reporting Tool

Age at time of onset of reaction/Date of birth

Medical history

Name or initials

Sex

Weight

Qualification

Reaction (text input)

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (list and text input)

Actions taken with drug

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

21

UAE RADR

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (list and text input)

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (list)

Actions taken with drug

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

22

Yellow Card Schemee

Age at time of onset of reaction/Date of birth

Height

Medical history

Name or initials

Sex

Weight

Email address

Qualification

Reporter’s name

Reaction (list and text input)

Date of start of reaction

Date of end of reaction

Outcome of reactions at the time of last observation

Seriousness criteria at event level

Drug name (list)

Actions taken with drug

Date of start of drug

Date of last administration

Dosage

Indication

Route of administration

  1. aConditions available for selection: allergies, liver problems, kidney problems, other medical conditions, works with industrial chemicals, alternative medicines, nutritional supplements, over-the-counter medicines
  2. bAvailable choices were limited to Bevax, Cimaher, Novex, Vaxira, Heberprot-P
  3. cAvailable choices were limited to lack of effectiveness, adverse event, others
  4. dOnly text input was available in the Armenia and Burkina Faso versions
  5. eThe same app was named Yellow Card—MHRA in iOS