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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125627481 | 12562748 | 1 | I | 20160504 | 20160706 | 20160715 | 20160715 | EXP | GB-MHRA-ADR23549509 | GB-009507513-1607GBR004921 | MERCK | 48.00 | YR | M | Y | 0.00000 | 20160715 | CN | IE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125627481 | 12562748 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 20 MG, ON DAYS 1, 2,4,5,8,9,11 AND 12 | Y | 12675 | 20 | MG | TABLET | ||||||
| 125627481 | 12562748 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 20 MG, UNKNOWN | Y | 12675 | 20 | MG | TABLET | ||||||
| 125627481 | 12562748 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 20 MG, UNKNOWN | Y | 12675 | 20 | MG | TABLET | ||||||
| 125627481 | 12562748 | 4 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2 2 IN 1 WK, ON DAYS 1,4,8 AND 11 CYCLE 1, BIW | 0 | 1.3 | MG/M**2 | POWDER | BIW | ||||||
| 125627481 | 12562748 | 5 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1 MG/M2 2 IN 1 WK, ON DAYS 1,4,8 AND 11 CYCLE 1 BIW | 0 | 1 | MG/M**2 | POWDER | BIW | ||||||
| 125627481 | 12562748 | 6 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1 MG/M2 2 IN 1 WK, ON DAYS 1,4,8 AND 11 CYCLE 1, BIW | 0 | 1 | MG/M**2 | POWDER | BIW | ||||||
| 125627481 | 12562748 | 7 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 800 MG, 2 IN 1 D | U | 0 | 800 | MG | BID | ||||||
| 125627481 | 12562748 | 8 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 300 MG, 1 IN 1 M | U | 0 | 300 | MG | /month | ||||||
| 125627481 | 12562748 | 9 | C | AMITRIPTYLINE HYDROCHLORIDE. | AMITRIPTYLINE HYDROCHLORIDE | 1 | Oral | 1 DF, 1 IN 1 D | U | 0 | 1 | DF | TABLET | QD | |||||
| 125627481 | 12562748 | 10 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 4 G, 4 IN 1 D | U | 0 | 4 | G | QID | ||||||
| 125627481 | 12562748 | 11 | C | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | 150 MG, 3 IN 1 D | U | 0 | 150 | MG | TID | ||||||
| 125627481 | 12562748 | 12 | C | CODEINE | CODEINE | 1 | Oral | 1 DF, 1 AS REQUIRED | U | 0 | |||||||||
| 125627481 | 12562748 | 13 | C | ZOPICLONE | ZOPICLONE | 1 | Oral | AT NIGHT, 1 IN 1 D | U | 0 | 1 | DF | QD | ||||||
| 125627481 | 12562748 | 14 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, 1 IN 1 D | U | 0 | 20 | MG | CAPSULE | QD | |||||
| 125627481 | 12562748 | 15 | C | LAXIDO | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Oral | 1 AS REQUIRED | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125627481 | 12562748 | 1 | Plasma cell myeloma |
| 125627481 | 12562748 | 4 | Plasma cell myeloma |
| 125627481 | 12562748 | 7 | Antiviral prophylaxis |
| 125627481 | 12562748 | 8 | Prophylaxis |
| 125627481 | 12562748 | 10 | Back pain |
| 125627481 | 12562748 | 11 | Back pain |
| 125627481 | 12562748 | 12 | Back pain |
| 125627481 | 12562748 | 13 | Insomnia |
| 125627481 | 12562748 | 14 | Gastrointestinal disorder therapy |
| 125627481 | 12562748 | 15 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125627481 | 12562748 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125627481 | 12562748 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125627481 | 12562748 | 1 | 20151214 | 0 | ||
| 125627481 | 12562748 | 2 | 20160418 | 20160509 | 0 | |
| 125627481 | 12562748 | 3 | 20160516 | 0 | ||
| 125627481 | 12562748 | 4 | 20151214 | 0 | ||
| 125627481 | 12562748 | 5 | 20160418 | 20160509 | 0 | |
| 125627481 | 12562748 | 6 | 20160516 | 0 | ||
| 125627481 | 12562748 | 7 | 20151214 | 0 | ||
| 125627481 | 12562748 | 8 | 20151214 | 0 | ||
| 125627481 | 12562748 | 9 | 20151221 | 0 | ||
| 125627481 | 12562748 | 12 | 2015 | 0 | ||
| 125627481 | 12562748 | 14 | 20151214 | 0 | ||
| 125627481 | 12562748 | 15 | 2015 | 0 |