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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126556244 | 12655624 | 4 | F | 2016 | 20160922 | 20160816 | 20160926 | EXP | FR-IPSEN BIOPHARMACEUTICALS, INC.-2016-06845 | IPSEN | 53.34 | YR | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126556244 | 12655624 | 1 | PS | SOMATULINE AUTOGEL | LANREOTIDE ACETATE | 1 | Intramuscular | 30 MG | D | 0 | 30 | MG | POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION | ||||||
| 126556244 | 12655624 | 2 | SS | SOMATULINE L.P. 90MG | LANREOTIDE ACETATE | 1 | Unknown | 90 MG | U | 0 | 90 | MG | SOLUTION FOR INJECTION/INFUSION | ||||||
| 126556244 | 12655624 | 3 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126556244 | 12655624 | 4 | SS | VANCOMYCINE | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126556244 | 12655624 | 5 | SS | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | 0 | |||||||||||
| 126556244 | 12655624 | 6 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126556244 | 12655624 | 7 | SS | IOMERON | IOMEPROL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126556244 | 12655624 | 8 | SS | IMOVANE | ZOPICLONE | 1 | Oral | 0 | |||||||||||
| 126556244 | 12655624 | 9 | SS | SKENAN | MORPHINE SULFATE | 1 | Oral | 0 | |||||||||||
| 126556244 | 12655624 | 10 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0 | |||||||||||
| 126556244 | 12655624 | 11 | SS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 126556244 | 12655624 | 12 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126556244 | 12655624 | 13 | SS | INEXIUM | ESOMEPRAZOLE | 1 | Oral | 0 | |||||||||||
| 126556244 | 12655624 | 14 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | 0 | ||||||||||||
| 126556244 | 12655624 | 15 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126556244 | 12655624 | 16 | C | ACTISKENAN | MORPHINE SULFATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126556244 | 12655624 | 1 | Pancreatic neuroendocrine tumour |
| 126556244 | 12655624 | 2 | Pancreatic neuroendocrine tumour |
| 126556244 | 12655624 | 3 | Liver abscess |
| 126556244 | 12655624 | 4 | Liver abscess |
| 126556244 | 12655624 | 5 | Thrombosis prophylaxis |
| 126556244 | 12655624 | 6 | Liver abscess |
| 126556244 | 12655624 | 7 | Computerised tomogram |
| 126556244 | 12655624 | 8 | Product used for unknown indication |
| 126556244 | 12655624 | 9 | Analgesic therapy |
| 126556244 | 12655624 | 10 | Procedural anxiety |
| 126556244 | 12655624 | 11 | Procedural anxiety |
| 126556244 | 12655624 | 12 | Analgesic therapy |
| 126556244 | 12655624 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126556244 | 12655624 | OT |
| 126556244 | 12655624 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126556244 | 12655624 | Drug reaction with eosinophilia and systemic symptoms | |
| 126556244 | 12655624 | Erythema | |
| 126556244 | 12655624 | Eyelid oedema | |
| 126556244 | 12655624 | Face oedema | |
| 126556244 | 12655624 | Liver abscess | |
| 126556244 | 12655624 | Lymphadenopathy | |
| 126556244 | 12655624 | Oedema peripheral | |
| 126556244 | 12655624 | Rash generalised | |
| 126556244 | 12655624 | Rash maculo-papular | |
| 126556244 | 12655624 | Toxic skin eruption |
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 |
|---|---|---|---|---|---|---|
| 126556244 | 12655624 | 1 | 20160629 | 20160629 | 0 | |
| 126556244 | 12655624 | 2 | 201509 | 0 | ||
| 126556244 | 12655624 | 3 | 20160118 | 20160711 | 0 | |
| 126556244 | 12655624 | 4 | 20160617 | 20160718 | 0 | |
| 126556244 | 12655624 | 5 | 20160621 | 20160715 | 0 | |
| 126556244 | 12655624 | 6 | 20160625 | 20160710 | 0 | |
| 126556244 | 12655624 | 7 | 20160629 | 20160629 | 0 | |
| 126556244 | 12655624 | 8 | 20160617 | 20160719 | 0 | |
| 126556244 | 12655624 | 9 | 20160617 | 20160723 | 0 | |
| 126556244 | 12655624 | 10 | 20160618 | 20160618 | 0 | |
| 126556244 | 12655624 | 11 | 20160618 | 20160618 | 0 | |
| 126556244 | 12655624 | 12 | 20160618 | 20160704 | 0 | |
| 126556244 | 12655624 | 13 | 20160617 | 20160719 | 0 |