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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121605335 | 12160533 | 5 | F | 20150325 | 20160816 | 20160308 | 20160819 | EXP | JP-JNJFOC-20160301782 | JANSSEN | 27.90 | YR | A | M | Y | 53.00000 | KG | 20160819 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121605335 | 12160533 | 1 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | 0 | 18 | MG | SUSTAINED RELEASE TABLETS | QD | ||||||
| 121605335 | 12160533 | 2 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | 0 | 27 | MG | SUSTAINED RELEASE TABLETS | QD | ||||||
| 121605335 | 12160533 | 3 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | 0 | 54 | MG | SUSTAINED RELEASE TABLETS | QD | ||||||
| 121605335 | 12160533 | 4 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | 0 | 63 | MG | SUSTAINED RELEASE TABLETS | QD | ||||||
| 121605335 | 12160533 | 5 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | 21121 | 63 | MG | SUSTAINED RELEASE TABLETS | QD | ||||||
| 121605335 | 12160533 | 6 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 0 | .5 | MG | SOLUTION | QD | |||||||
| 121605335 | 12160533 | 7 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 0 | 1 | MG | SOLUTION | ||||||||
| 121605335 | 12160533 | 8 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 | 1 | MG | UNSPECIFIED | ||||||||
| 121605335 | 12160533 | 9 | C | LEXOTAN | BROMAZEPAM | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 121605335 | 12160533 | 10 | C | ROHYPNOL | FLUNITRAZEPAM | 1 | Oral | 0 | 2 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121605335 | 12160533 | 1 | Attention deficit/hyperactivity disorder |
| 121605335 | 12160533 | 2 | Attention deficit/hyperactivity disorder |
| 121605335 | 12160533 | 3 | Attention deficit/hyperactivity disorder |
| 121605335 | 12160533 | 4 | Attention deficit/hyperactivity disorder |
| 121605335 | 12160533 | 5 | Attention deficit/hyperactivity disorder |
| 121605335 | 12160533 | 6 | Autism spectrum disorder |
| 121605335 | 12160533 | 7 | Autism spectrum disorder |
| 121605335 | 12160533 | 8 | Bipolar disorder |
| 121605335 | 12160533 | 9 | Social anxiety disorder |
| 121605335 | 12160533 | 10 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121605335 | 12160533 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121605335 | 12160533 | Completed suicide | |
| 121605335 | 12160533 | Decreased appetite | |
| 121605335 | 12160533 | Drug abuse |
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 |
|---|---|---|---|---|---|---|
| 121605335 | 12160533 | 1 | 20150318 | 20150401 | 0 | |
| 121605335 | 12160533 | 2 | 20150402 | 20150408 | 0 | |
| 121605335 | 12160533 | 3 | 20150409 | 20150527 | 0 | |
| 121605335 | 12160533 | 4 | 20150528 | 20150624 | 0 | |
| 121605335 | 12160533 | 5 | 20150625 | 20151115 | 0 | |
| 121605335 | 12160533 | 6 | 20151115 | 0 | ||
| 121605335 | 12160533 | 7 | 20150415 | 20151115 | 0 | |
| 121605335 | 12160533 | 8 | 20151115 | 0 | ||
| 121605335 | 12160533 | 9 | 20151115 | 0 | ||
| 121605335 | 12160533 | 10 | 20151115 | 0 |