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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126077682 | 12607768 | 2 | F | 20151104 | 20160908 | 20160729 | 20160912 | EXP | US-JNJFOC-20160720254 | JANSSEN | 34.34 | YR | A | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126077682 | 12607768 | 1 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | SIB3801 | 0 | 234 | MG | INJECTION | ||||||
| 126077682 | 12607768 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | 156 MG OR 234 MG | N | SIB3801 | 0 | INJECTION | |||||||
| 126077682 | 12607768 | 3 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | SIB3801 | 22264 | 156 | MG | INJECTION | ||||||
| 126077682 | 12607768 | 4 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 126077682 | 12607768 | 5 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 0 | 200 | MG | UNSPECIFIED | ||||||||
| 126077682 | 12607768 | 6 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 0 | 1500 | MG | UNSPECIFIED | BID | |||||||
| 126077682 | 12607768 | 7 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | QD | |||||||
| 126077682 | 12607768 | 8 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 0 | 2 | MG | UNSPECIFIED | QD | |||||||
| 126077682 | 12607768 | 9 | C | ATIVAN | LORAZEPAM | 1 | Oral | 0 | 1 | MG | UNSPECIFIED | ||||||||
| 126077682 | 12607768 | 10 | C | TOPAMAX | TOPIRAMATE | 1 | Unknown | 0 | 200 | MG | UNSPECIFIED | ||||||||
| 126077682 | 12607768 | 11 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 126077682 | 12607768 | 12 | C | DIVALPROEX SODIUM. | DIVALPROEX SODIUM | 1 | Unknown | 3Q AFTER DINNER | 0 | 500 | MG | UNSPECIFIED | |||||||
| 126077682 | 12607768 | 13 | C | CLOZAPINE. | CLOZAPINE | 1 | Unknown | 3Q AFTER DINNER | 0 | 500 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126077682 | 12607768 | 1 | Product used for unknown indication |
| 126077682 | 12607768 | 2 | Product used for unknown indication |
| 126077682 | 12607768 | 3 | Product used for unknown indication |
| 126077682 | 12607768 | 4 | Product used for unknown indication |
| 126077682 | 12607768 | 5 | Product used for unknown indication |
| 126077682 | 12607768 | 6 | Product used for unknown indication |
| 126077682 | 12607768 | 7 | Product used for unknown indication |
| 126077682 | 12607768 | 8 | Product used for unknown indication |
| 126077682 | 12607768 | 9 | Product used for unknown indication |
| 126077682 | 12607768 | 10 | Product used for unknown indication |
| 126077682 | 12607768 | 11 | Product used for unknown indication |
| 126077682 | 12607768 | 12 | Product used for unknown indication |
| 126077682 | 12607768 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126077682 | 12607768 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126077682 | 12607768 | Abscess oral | |
| 126077682 | 12607768 | Aggression | |
| 126077682 | 12607768 | Asthenia | |
| 126077682 | 12607768 | Back pain | |
| 126077682 | 12607768 | Choking | |
| 126077682 | 12607768 | Drooling | |
| 126077682 | 12607768 | Hypersomnia | |
| 126077682 | 12607768 | Inappropriate schedule of drug administration | |
| 126077682 | 12607768 | Off label use | |
| 126077682 | 12607768 | Overdose | |
| 126077682 | 12607768 | Seizure | |
| 126077682 | 12607768 | Snoring | |
| 126077682 | 12607768 | Speech disorder | |
| 126077682 | 12607768 | Treatment noncompliance | |
| 126077682 | 12607768 | Vomiting | |
| 126077682 | 12607768 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 126077682 | 12607768 | 3 | 201511 | 0 |