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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124222892 | 12422289 | 2 | F | 2016 | 20160602 | 20160601 | 20160829 | PER | US-JNJFOC-20160417720 | JANSSEN | 0.00 | A | F | Y | 65.77000 | KG | 20160829 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124222892 | 12422289 | 1 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | IN MORNING | N | UNKNOWN | 0 | 126 | MG | SUSTAINED RELEASE TABLETS | QD | ||||
| 124222892 | 12422289 | 2 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | IN THE AFTERNOON | N | UNKNOWN | 0 | 99 | MG | SUSTAINED RELEASE TABLETS | QD | ||||
| 124222892 | 12422289 | 3 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | UNKNOWN | 0 | 72 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 124222892 | 12422289 | 4 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | UNKNOWN | 0 | 90 | MG | SUSTAINED RELEASE TABLETS | ||||||
| 124222892 | 12422289 | 5 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | N | UNKNOWN | 21121 | 108 | MG | SUSTAINED RELEASE TABLETS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124222892 | 12422289 | 1 | Attention deficit/hyperactivity disorder |
| 124222892 | 12422289 | 2 | Attention deficit/hyperactivity disorder |
| 124222892 | 12422289 | 3 | Attention deficit/hyperactivity disorder |
| 124222892 | 12422289 | 4 | Attention deficit/hyperactivity disorder |
| 124222892 | 12422289 | 5 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124222892 | 12422289 | Abnormal loss of weight | |
| 124222892 | 12422289 | Adverse event | |
| 124222892 | 12422289 | Alopecia | |
| 124222892 | 12422289 | Drug effect increased | |
| 124222892 | 12422289 | Hair texture abnormal | |
| 124222892 | 12422289 | Headache | |
| 124222892 | 12422289 | Mood swings | |
| 124222892 | 12422289 | Muscle tightness | |
| 124222892 | 12422289 | Oligodipsia | |
| 124222892 | 12422289 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 124222892 | 12422289 | 1 | 201601 | 0 | ||
| 124222892 | 12422289 | 2 | 201601 | 0 | ||
| 124222892 | 12422289 | 3 | 201601 | 2016 | 0 | |
| 124222892 | 12422289 | 4 | 2016 | 2016 | 0 | |
| 124222892 | 12422289 | 5 | 2016 | 2016 | 0 |