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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124117375 | 12411737 | 5 | F | 20140606 | 20160830 | 20160527 | 20160905 | EXP | JP-IPSEN BIOPHARMACEUTICALS, INC.-2016-04557 | IPSEN | 24.34 | YR | M | Y | 0.00000 | 20160905 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124117375 | 12411737 | 1 | PS | SOMATULINE AUTOGEL | LANREOTIDE ACETATE | 1 | Subcutaneous | 90 MG | Y | Y | NOT REPORTED | 0 | 90 | MG | SOLUTION FOR INJECTION/INFUSION | ||||
| 124117375 | 12411737 | 2 | SS | SOMATULINE AUTOGEL | LANREOTIDE ACETATE | 1 | Subcutaneous | 90 MG | Y | Y | NOT REPORTED | 0 | 90 | MG | SOLUTION FOR INJECTION/INFUSION | ||||
| 124117375 | 12411737 | 3 | SS | SOMATULINE AUTOGEL | LANREOTIDE ACETATE | 1 | Subcutaneous | 90 MG | Y | Y | NOT REPORTED | 0 | 90 | MG | SOLUTION FOR INJECTION/INFUSION | ||||
| 124117375 | 12411737 | 4 | SS | CABASER | CABERGOLINE | 1 | Oral | 0 | .25 | MG | /wk | ||||||||
| 124117375 | 12411737 | 5 | SS | CORTRIL | HYDROCORTISONE | 1 | Oral | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124117375 | 12411737 | 1 | Acromegaly |
| 124117375 | 12411737 | 4 | Acromegaly |
| 124117375 | 12411737 | 5 | Adrenal insufficiency |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124117375 | 12411737 | LT |
| 124117375 | 12411737 | OT |
| 124117375 | 12411737 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124117375 | 12411737 | Abdominal pain | Abdominal pain |
| 124117375 | 12411737 | Barrett's oesophagus | |
| 124117375 | 12411737 | Depressed level of consciousness | |
| 124117375 | 12411737 | Diarrhoea | Diarrhoea |
| 124117375 | 12411737 | Feeling abnormal | |
| 124117375 | 12411737 | Flatulence | |
| 124117375 | 12411737 | Gastric dilatation | |
| 124117375 | 12411737 | Gastrooesophageal reflux disease | |
| 124117375 | 12411737 | Hypotension | |
| 124117375 | 12411737 | Inappropriate schedule of drug administration | |
| 124117375 | 12411737 | Intestinal ischaemia | |
| 124117375 | 12411737 | Mallory-Weiss syndrome | |
| 124117375 | 12411737 | Metabolic acidosis | |
| 124117375 | 12411737 | Portal venous gas | |
| 124117375 | 12411737 | Ulcer | |
| 124117375 | 12411737 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124117375 | 12411737 | 1 | 20140605 | 20140828 | 0 | |
| 124117375 | 12411737 | 2 | 20140925 | 20150115 | 0 | |
| 124117375 | 12411737 | 3 | 20150115 | 20160512 | 0 | |
| 124117375 | 12411737 | 4 | 2013 | 0 | ||
| 124117375 | 12411737 | 5 | 20140422 | 20160512 | 0 |