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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124607633 | 12460763 | 3 | F | 20160322 | 20160817 | 20160613 | 20160824 | EXP | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201606-002881 | CONCORDIA | 75.00 | YR | M | Y | 99.00000 | KG | 20160824 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124607633 | 12460763 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | DOSAGE FORM: UNSPECIFIED, DAY 1,2,3,4 | U | 21959 | 130 | MG | |||||||
| 124607633 | 12460763 | 2 | SS | MELPHALAN | MELPHALAN | 1 | Oral | DOSAGE FORM: UNSPECIFIED, DAY 1,2,3,4 | U | 0 | 20 | MG | |||||||
| 124607633 | 12460763 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | DOSAGE FORM: LYOPHILIZED POWDER, DAY 1, 4, 8, 11, 22, 25, 29 AND 32 | U | V15541-09;1537301;1537302 | 0 | 2.75 | MG | ||||||
| 124607633 | 12460763 | 4 | C | ACICLOVIR | ACYCLOVIR | 1 | Oral | 3200 | MG | 0 | 200 | MG | TABLET | QID | |||||
| 124607633 | 12460763 | 5 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 1200 | MG | 0 | 300 | MG | TABLET | QD | |||||
| 124607633 | 12460763 | 6 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 124607633 | 12460763 | 7 | C | COCODAMOL | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Oral | 0 | 2 | DF | TABLET | ||||||||
| 124607633 | 12460763 | 8 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | Oral | 0 | 4 | MG | TABLET | QD | |||||||
| 124607633 | 12460763 | 9 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 0 | 2 | MG | CAPSULE | ||||||||
| 124607633 | 12460763 | 10 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 0 | 10 | MG | TABLET | ||||||||
| 124607633 | 12460763 | 11 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 0 | 10 | MG | TABLET | ||||||||
| 124607633 | 12460763 | 12 | C | RAMIPRIL. | RAMIPRIL | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 124607633 | 12460763 | 13 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 1200 | MG | 0 | 150 | MG | TABLET | BID | |||||
| 124607633 | 12460763 | 14 | C | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | DOSAGE FORM: POWDER, CUMULATIVE DOSE TO FIRST REACTION WAS 0.13333333 | .13333333 | MG | 0 | 4 | MG | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124607633 | 12460763 | 1 | Plasma cell myeloma |
| 124607633 | 12460763 | 2 | Plasma cell myeloma |
| 124607633 | 12460763 | 3 | Plasma cell myeloma |
| 124607633 | 12460763 | 4 | Antiviral prophylaxis |
| 124607633 | 12460763 | 5 | Prophylaxis |
| 124607633 | 12460763 | 6 | Hypertension |
| 124607633 | 12460763 | 7 | Pain |
| 124607633 | 12460763 | 8 | Hypertension |
| 124607633 | 12460763 | 9 | Diarrhoea |
| 124607633 | 12460763 | 10 | Prophylaxis of nausea and vomiting |
| 124607633 | 12460763 | 11 | Prophylaxis of nausea and vomiting |
| 124607633 | 12460763 | 12 | Hypertension |
| 124607633 | 12460763 | 13 | Prophylaxis |
| 124607633 | 12460763 | 14 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124607633 | 12460763 | HO |
| 124607633 | 12460763 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124607633 | 12460763 | Diarrhoea | |
| 124607633 | 12460763 | Eye infection | |
| 124607633 | 12460763 | Herpes zoster | |
| 124607633 | 12460763 | Neutrophil count decreased |
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 |
|---|---|---|---|---|---|---|
| 124607633 | 12460763 | 1 | 20160318 | 20160321 | 0 | |
| 124607633 | 12460763 | 2 | 20160318 | 20160321 | 0 | |
| 124607633 | 12460763 | 3 | 20160318 | 20160328 | 0 | |
| 124607633 | 12460763 | 4 | 20160318 | 20160407 | 0 | |
| 124607633 | 12460763 | 5 | 20160318 | 20160428 | 0 | |
| 124607633 | 12460763 | 9 | 20160322 | 20160324 | 0 | |
| 124607633 | 12460763 | 10 | 20160318 | 0 | ||
| 124607633 | 12460763 | 11 | 20160318 | 0 | ||
| 124607633 | 12460763 | 13 | 20160318 | 0 | ||
| 124607633 | 12460763 | 14 | 20160321 | 0 |