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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116138944 | 11613894 | 4 | F | 200511 | 20160719 | 20151008 | 20160728 | EXP | PHHO2015DE015010 | NOVARTIS | 76.00 | YR | M | Y | 60.00000 | KG | 20160728 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116138944 | 11613894 | 1 | PS | LBH589 | PANOBINOSTAT | 1 | Oral | 20 MG | Y | 205353 | 20 | MG | CAPSULE | ||||||
| 116138944 | 11613894 | 2 | SS | LBH589 | PANOBINOSTAT | 1 | Oral | 15 MG | Y | 205353 | 15 | MG | CAPSULE | ||||||
| 116138944 | 11613894 | 3 | SS | LBH589 | PANOBINOSTAT | 1 | Oral | 10 MG, UNK | Y | 205353 | 10 | MG | CAPSULE | ||||||
| 116138944 | 11613894 | 4 | SS | BORTEZOMIB | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2 | Y | 0 | 1.3 | MG/M**2 | |||||||
| 116138944 | 11613894 | 5 | SS | BORTEZOMIB | BORTEZOMIB | 1 | Subcutaneous | 1 UNK, UNK | Y | 0 | |||||||||
| 116138944 | 11613894 | 6 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 20 MG | Y | 0 | 20 | MG | |||||||
| 116138944 | 11613894 | 7 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 116138944 | 11613894 | 8 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | 400 MG, 1-2-1 | 0 | 400 | MG | ||||||||
| 116138944 | 11613894 | 9 | C | OXAZEPAM. | OXAZEPAM | 1 | Unknown | ON DEXMETHASONE DAY | 0 | ||||||||||
| 116138944 | 11613894 | 10 | C | PENTAMIDINE | PENTAMIDINE | 1 | Respiratory (inhalation) | ONCE A MONTH | 0 | ||||||||||
| 116138944 | 11613894 | 11 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Unknown | EVERY FOUR WEEKS | 0 | ||||||||||
| 116138944 | 11613894 | 12 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Unknown | 20 MG | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116138944 | 11613894 | 1 | Plasma cell myeloma |
| 116138944 | 11613894 | 4 | Plasma cell myeloma |
| 116138944 | 11613894 | 6 | Plasma cell myeloma |
| 116138944 | 11613894 | 7 | Infection prophylaxis |
| 116138944 | 11613894 | 8 | Antiviral prophylaxis |
| 116138944 | 11613894 | 9 | Sleep disorder |
| 116138944 | 11613894 | 10 | Infection prophylaxis |
| 116138944 | 11613894 | 11 | Prophylaxis |
| 116138944 | 11613894 | 12 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116138944 | 11613894 | HO |
| 116138944 | 11613894 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116138944 | 11613894 | Asthenia | |
| 116138944 | 11613894 | Atrial fibrillation | |
| 116138944 | 11613894 | Fatigue | |
| 116138944 | 11613894 | Polyneuropathy | |
| 116138944 | 11613894 | Tachyarrhythmia | |
| 116138944 | 11613894 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 116138944 | 11613894 | 1 | 201509 | 201510 | 0 | |
| 116138944 | 11613894 | 2 | 201510 | 201511 | 0 | |
| 116138944 | 11613894 | 3 | 201511 | 201511 | 0 | |
| 116138944 | 11613894 | 4 | 201509 | 201511 | 0 | |
| 116138944 | 11613894 | 5 | 201511 | 201511 | 0 | |
| 116138944 | 11613894 | 6 | 201509 | 201511 | 0 | |
| 116138944 | 11613894 | 7 | 20150918 | 0 | ||
| 116138944 | 11613894 | 8 | 20150918 | 0 | ||
| 116138944 | 11613894 | 9 | 20150918 | 0 | ||
| 116138944 | 11613894 | 10 | 20151015 | 0 | ||
| 116138944 | 11613894 | 11 | 201408 | 0 | ||
| 116138944 | 11613894 | 12 | 20151205 | 0 |