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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127833391 | 12783339 | 1 | I | 2012 | 20160921 | 20160927 | 20160927 | EXP | DE-IPSEN BIOPHARMACEUTICALS, INC.-2016-07892 | IPSEN | 53.00 | YR | F | Y | 53.00000 | KG | 20160927 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127833391 | 12783339 | 1 | PS | SOMATULINE AUTOGEL | LANREOTIDE ACETATE | 1 | Subcutaneous | 60 MG | U | 0 | 60 | MG | SOLUTION FOR INJECTION/INFUSION | ||||||
| 127833391 | 12783339 | 2 | SS | SOMATULINE AUTOGEL | LANREOTIDE ACETATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127833391 | 12783339 | 1 | Pituitary tumour benign |
| 127833391 | 12783339 | 2 | Product use issue |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127833391 | 12783339 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127833391 | 12783339 | Acromegaly | |
| 127833391 | 12783339 | Haemorrhage | |
| 127833391 | 12783339 | Inappropriate schedule of drug administration | |
| 127833391 | 12783339 | Magnesium deficiency | |
| 127833391 | 12783339 | Muscle spasms | |
| 127833391 | 12783339 | Vitamin A deficiency | |
| 127833391 | 12783339 | Vitamin K deficiency |
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 |
|---|---|---|---|---|---|---|
| 127833391 | 12783339 | 1 | 201211 | 0 |