Table 3.
Range of data elements collecting information about rechallenge to the suspect drug
| No. | Rechallenge data elements |
|---|---|
| 1 | Adverse event or reaction reappeared on rechallenge |
| 2 | Check reaction at rechallenge? |
| 3 | Did adverse reaction re‐appear upon re‐use? |
| 4 | Did re‐exposure to the suspect cause the same or a similar reaction? |
| 5 | Did the ADR reappear after the drug was restarted? |
| 6 | Did the ADR reappear after readministering the suspect drug? |
| 7 | Did the adverse reaction reappear, when the drugs was readministered? |
| 8 | Did the event reappear after re‐administering the medication? |
| 9 | Did the problem reappear after introduction of the suspected drug again? |
| 10 | Did the reaction appear after reintroducing the suspected product? |
| 11 | Did the reaction reappear after drug was stopped? |
| 12 | Did the reaction reappear after reintroduction |
| 13 | Did the reaction reappear after reintroduction of the drug? |
| 14 | Did the reaction reappear after suspect drug was restarted? |
| 15 | Did the reaction reappear after the drug was reintroduced? |
| 16 | Did the reaction reappear if product was re‐introduced? |
| 17 | Does the reaction reappear after retaking the drug? |
| 18 | Event appeared on rechallenge |
| 19 | Event reappeared after the drug is reintroduced? |
| 20 | Event reappeared on use |
| 21 | If [a rechallenge happened] did the undesirable effect recur? |
| 22 | If [there has been improvement after the medication was discontinued] was/were the medication(s) readministered?(=rechallenge) |
| 22 | If the medication was readministered, the undesirable effect reappear? |
| 23 | Int: Was the medication re‐administered? |
| 24 | No rechallenge performed |
| 25 | One or more side effects after re‐exposure occurred? |
| 26 | Problem returned after person started taking or using the product again? |
| 27 | Reaction appeared after reintroduction (rechallenge) |
| 28 | Reaction reappear after restart of suspected drug |
| 29 | Reaction reappeared after reintroducing drug |
| 30 | Reaction reappeared after reintroduction |
| 31 | Reappearance of event with readministration |
| 32 | Reappearance of the reaction after re‐introduction of the medication? |
| 33 | Rechallenge |
| 34 | Rechallenge generated the same or similar adverse reaction |
| 35 | Rechallenge not done |
| 36 | Rechallenge to the product? |
| 37 | Rechallenged? |
| 38 | Reintroduction of product |
| 39 | Result on reintroduction of the drug |
| 40 | The reaction reoccurred if the drug was used again? |
| 41 | Was product re‐used after detection of adverse reaction (re‐challenge)? |
| 42 | Was the patient re‐exposed to the drug? |
| 43 | Was there an adverse event on drug re‐administration? |
| 44 | Was there one or more side effects after re‐exposure? |
| 45 | Which adverse event recurred on drug re‐administration? |