Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125499463 | 12549946 | 3 | F | 20141027 | 20160803 | 20160712 | 20160808 | EXP | JP-JNJFOC-20160707533 | JANSSEN | 6.59 | YR | C | M | Y | 23.00000 | KG | 20160808 | PH | JP | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125499463 | 12549946 | 1 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | Y | N | 0 | 18 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 125499463 | 12549946 | 2 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | Y | N | 0 | 27 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 125499463 | 12549946 | 3 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | Y | N | 21121 | 18 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 125499463 | 12549946 | 4 | SS | STRATTERA | ATOMOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 4.5 | ML | LIQUID | BID | |||||||
| 125499463 | 12549946 | 5 | SS | STRATTERA | ATOMOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 3 | ML | LIQUID | BID | |||||||
| 125499463 | 12549946 | 6 | SS | STRATTERA | ATOMOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 3.8 | ML | LIQUID | BID | |||||||
| 125499463 | 12549946 | 7 | SS | STRATTERA | ATOMOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 1.3 | ML | LIQUID | BID | |||||||
| 125499463 | 12549946 | 8 | SS | STRATTERA | ATOMOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 2 | ML | LIQUID | BID | |||||||
| 125499463 | 12549946 | 9 | SS | LUVOX | FLUVOXAMINE MALEATE | 1 | Oral | 0 | 25 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125499463 | 12549946 | 1 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 2 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 3 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 4 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 5 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 6 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 7 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 8 | Attention deficit/hyperactivity disorder |
| 125499463 | 12549946 | 9 | Irritability |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125499463 | 12549946 | Decreased appetite | |
| 125499463 | 12549946 | Tic |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125499463 | 12549946 | 1 | 20160623 | 20160706 | 0 | |
| 125499463 | 12549946 | 2 | 20141014 | 20141102 | 0 | |
| 125499463 | 12549946 | 3 | 20140611 | 20141013 | 0 | |
| 125499463 | 12549946 | 4 | 20141213 | 0 | ||
| 125499463 | 12549946 | 5 | 20141128 | 20141204 | 0 | |
| 125499463 | 12549946 | 6 | 20141205 | 20141212 | 0 | |
| 125499463 | 12549946 | 7 | 20141112 | 20141119 | 0 | |
| 125499463 | 12549946 | 8 | 20141120 | 20141127 | 0 | |
| 125499463 | 12549946 | 9 | 20150618 | 0 |