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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123565103 | 12356510 | 3 | F | 201211 | 20160919 | 20160511 | 20160928 | EXP | BR-JNJFOC-20141217622 | JANSSEN | 53.68 | YR | A | F | Y | 80.00000 | KG | 20160928 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123565103 | 12356510 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;FCL23016;UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 123565103 | 12356510 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;FCL23016;UNKNOWN | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 123565103 | 12356510 | 3 | C | RISPERIDONE. | RISPERIDONE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 123565103 | 12356510 | 4 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 123565103 | 12356510 | 5 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | D | 0 | 20 | MG | UNSPECIFIED | |||||||
| 123565103 | 12356510 | 6 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 123565103 | 12356510 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 123565103 | 12356510 | 8 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | D | 0 | 100 | MG | UNSPECIFIED | |||||||
| 123565103 | 12356510 | 9 | C | PROMETAZIN | 2 | Unknown | D | 0 | UNSPECIFIED | ||||||||||
| 123565103 | 12356510 | 10 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123565103 | 12356510 | 1 | Psoriasis |
| 123565103 | 12356510 | 2 | Psoriasis |
| 123565103 | 12356510 | 3 | Mental disorder |
| 123565103 | 12356510 | 4 | Mental disorder |
| 123565103 | 12356510 | 5 | Mental disorder |
| 123565103 | 12356510 | 6 | Mental disorder |
| 123565103 | 12356510 | 7 | Mental disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123565103 | 12356510 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123565103 | 12356510 | Dissociative disorder | |
| 123565103 | 12356510 | Drug effect decreased | |
| 123565103 | 12356510 | Haemorrhage | |
| 123565103 | 12356510 | Inappropriate schedule of drug administration | |
| 123565103 | 12356510 | Major depression | |
| 123565103 | 12356510 | Off label use | |
| 123565103 | 12356510 | Product use issue | |
| 123565103 | 12356510 | Psoriasis | |
| 123565103 | 12356510 | 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 |
|---|---|---|---|---|---|---|
| 123565103 | 12356510 | 1 | 201112 | 0 | ||
| 123565103 | 12356510 | 2 | 201211 | 0 |