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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126213301 | 12621330 | 1 | I | 20160725 | 20160730 | 20160804 | 20160804 | EXP | PHHY2016BR106463 | NOVARTIS | 9.02 | YR | M | Y | 27.00000 | KG | 20160804 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126213301 | 12621330 | 1 | PS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | Y | 10187 | 1 | DF | TABLET | QD | |||||
| 126213301 | 12621330 | 2 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Y | 10187 | TABLET | ||||||||||
| 126213301 | 12621330 | 3 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Y | 10187 | TABLET | ||||||||||
| 126213301 | 12621330 | 4 | SS | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 10 MG, QD (FOR 1 MONTH) | U | SA436 | 0 | 10 | MG | EXTENDED RELEASE CAPSULES | QD | ||||
| 126213301 | 12621330 | 5 | SS | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 20 MG, QD (ONE MONTH AGO) | U | SA438 | 0 | 20 | MG | EXTENDED RELEASE CAPSULES | QD | ||||
| 126213301 | 12621330 | 6 | SS | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | EXTENDED RELEASE CAPSULES |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126213301 | 12621330 | 1 | Disturbance in attention |
| 126213301 | 12621330 | 2 | Depression |
| 126213301 | 12621330 | 3 | Agitation |
| 126213301 | 12621330 | 4 | Disturbance in attention |
| 126213301 | 12621330 | 5 | Depression |
| 126213301 | 12621330 | 6 | Agitation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126213301 | 12621330 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126213301 | 12621330 | Asthenia | |
| 126213301 | 12621330 | Conjunctivitis | |
| 126213301 | 12621330 | Decreased appetite | |
| 126213301 | 12621330 | Disturbance in attention | |
| 126213301 | 12621330 | Drug ineffective | |
| 126213301 | 12621330 | Hypophagia | |
| 126213301 | 12621330 | Infection susceptibility increased | |
| 126213301 | 12621330 | Influenza | |
| 126213301 | 12621330 | Nasopharyngitis | |
| 126213301 | 12621330 | Pyrexia | |
| 126213301 | 12621330 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126213301 | 12621330 | 1 | 201509 | 201603 | 0 | |
| 126213301 | 12621330 | 4 | 201605 | 0 |