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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127962981 | 12796298 | 1 | I | 20160920 | 20160929 | 20160929 | EXP | FR-JNJFOC-20160924823 | JANSSEN | CUNY P, HOUOT M, GINISTY S, HOROWICZ S, PLASSART F, MENTEC H. QUETIAPINE AND ANTICHOLINERGIC DRUGS INDUCED ISCHAEMIC COLITIS: A CASE STUDY. ENCEPHALE 2016. | 34.00 | YR | A | M | Y | 0.00000 | 20160929 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127962981 | 12796298 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Unknown | D | N | 20281 | UNSPECIFIED | ||||||||
| 127962981 | 12796298 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | D | N | UNKNOWN | 20272 | UNSPECIFIED | ||||||||
| 127962981 | 12796298 | 3 | SS | DIAZEPAM. | DIAZEPAM | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127962981 | 12796298 | 4 | SS | LOXAPINE. | LOXAPINE | 1 | Oral | D | 0 | ORAL SOLUTION | |||||||||
| 127962981 | 12796298 | 5 | SS | QUETIAPINE. | QUETIAPINE | 1 | Unknown | D | UNKNOWN | 0 | 600 | MG | UNSPECIFIED | ||||||
| 127962981 | 12796298 | 6 | SS | QUETIAPINE. | QUETIAPINE | 1 | Unknown | D | UNKNOWN | 0 | UNSPECIFIED | ||||||||
| 127962981 | 12796298 | 7 | SS | QUETIAPINE. | QUETIAPINE | 1 | Unknown | D | UNKNOWN | 0 | UNSPECIFIED | ||||||||
| 127962981 | 12796298 | 8 | SS | QUETIAPINE. | QUETIAPINE | 1 | Unknown | D | UNKNOWN | 0 | 600 | MG | UNSPECIFIED | ||||||
| 127962981 | 12796298 | 9 | SS | MORPHINE | MORPHINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127962981 | 12796298 | 10 | SS | TROPATEPINE | TROPATEPINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127962981 | 12796298 | 11 | SS | TROPATEPINE | TROPATEPINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127962981 | 12796298 | 12 | SS | TROPATEPINE | TROPATEPINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127962981 | 12796298 | 13 | SS | TROPATEPINE | TROPATEPINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127962981 | 12796298 | 14 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | D | UNKNOWN | 0 | UNSPECIFIED | ||||||||
| 127962981 | 12796298 | 15 | SS | LOXAPINE. | LOXAPINE | 1 | Unknown | D | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127962981 | 12796298 | 1 | Product used for unknown indication |
| 127962981 | 12796298 | 2 | Bipolar disorder |
| 127962981 | 12796298 | 3 | Product used for unknown indication |
| 127962981 | 12796298 | 4 | Product used for unknown indication |
| 127962981 | 12796298 | 5 | Aggression |
| 127962981 | 12796298 | 6 | Aggression |
| 127962981 | 12796298 | 7 | Agitation |
| 127962981 | 12796298 | 8 | Agitation |
| 127962981 | 12796298 | 9 | Product used for unknown indication |
| 127962981 | 12796298 | 10 | Aggression |
| 127962981 | 12796298 | 11 | Aggression |
| 127962981 | 12796298 | 12 | Agitation |
| 127962981 | 12796298 | 13 | Agitation |
| 127962981 | 12796298 | 14 | Product used for unknown indication |
| 127962981 | 12796298 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127962981 | 12796298 | HO |
| 127962981 | 12796298 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127962981 | 12796298 | Bacterial infection | |
| 127962981 | 12796298 | Cardiac arrest | |
| 127962981 | 12796298 | Condition aggravated | |
| 127962981 | 12796298 | Fungal infection | |
| 127962981 | 12796298 | Intestinal ischaemia | |
| 127962981 | 12796298 | Mesenteric vascular occlusion | |
| 127962981 | 12796298 | Multiple organ dysfunction syndrome | |
| 127962981 | 12796298 | Necrotising colitis | |
| 127962981 | 12796298 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 127962981 | 12796298 | 1 | 20120625 | 0 | ||
| 127962981 | 12796298 | 3 | 20120614 | 0 | ||
| 127962981 | 12796298 | 4 | 20120614 | 0 | ||
| 127962981 | 12796298 | 5 | 20120605 | 0 | ||
| 127962981 | 12796298 | 8 | 20120605 | 0 | ||
| 127962981 | 12796298 | 9 | 20120625 | 0 | ||
| 127962981 | 12796298 | 10 | 20120605 | 0 | ||
| 127962981 | 12796298 | 13 | 20120605 | 0 | ||
| 127962981 | 12796298 | 14 | 20120614 | 0 | ||
| 127962981 | 12796298 | 15 | 20120625 | 0 |