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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92140155 | 9214015 | 5 | F | 20130222 | 20140409 | 20130405 | 20160912 | EXP | CH-CELGENEUS-151-21880-13030279 | CELGENE | 60.42 | YR | F | Y | 50.70000 | KG | 20160912 | OT | CH | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 92140155 | 9214015 | 1 | PS | REVLIMID | LENALIDOMIDE | 1 | Oral | DAY 1-21 | Y | U | 21880 | 25 | MG | CAPSULES | |||||
| 92140155 | 9214015 | 2 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | DAY 1-21 | Y | U | 21880 | 25 | MG | CAPSULES | |||||
| 92140155 | 9214015 | 3 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | Y | U | 21880 | CAPSULES | ||||||||
| 92140155 | 9214015 | 4 | SS | Bendamustine | BENDAMUSTINE | 1 | Intravenous drip | DAY 1-2 | Y | U | 0 | 115 | MG | INJECTION | |||||
| 92140155 | 9214015 | 5 | SS | Bendamustine | BENDAMUSTINE | 1 | Intravenous drip | DAY 1-2 | Y | U | 0 | 115 | MG | SOLUTION | |||||
| 92140155 | 9214015 | 6 | SS | Bendamustine | BENDAMUSTINE | 1 | Unknown | Y | U | 0 | UNKNOWN | ||||||||
| 92140155 | 9214015 | 7 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | DAY 1+8+15+22 | U | U | 0 | 40 | MG | TABLETS | |||||
| 92140155 | 9214015 | 8 | SS | CC-5013 | LENALIDOMIDE | 1 | 60100 | ||||||||||||
| 92140155 | 9214015 | 9 | SS | REVLIMID | LENALIDOMIDE | 1 | 21880 | ||||||||||||
| 92140155 | 9214015 | 10 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 5000 IU (INTERNATIONAL UNIT) | 0 | 4000 | MG | UNKNOWN | QD | ||||||
| 92140155 | 9214015 | 11 | C | TRIMETOPRIM W/SULFAMETOXAZOL | 2 | Oral | 800MG/160MG | 0 | 1 | DF | TABLETS | TIW | |||||||
| 92140155 | 9214015 | 12 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 | 1000 | MG | UNKNOWN | QD | |||||||
| 92140155 | 9214015 | 13 | C | DALTEPARIN | DALTEPARIN | 1 | Subcutaneous | 1000 MILLIGRAM | 0 | 5000 | IU | UNKNOWN | QD | ||||||
| 92140155 | 9214015 | 14 | C | PAMIDRONATE | PAMIDRONATE DISODIUM | 1 | Intravenous drip | 0 | 30 | MG | UNKNOWN | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 92140155 | 9214015 | 1 | Plasma cell myeloma |
| 92140155 | 9214015 | 4 | Plasma cell myeloma |
| 92140155 | 9214015 | 7 | Plasma cell myeloma |
| 92140155 | 9214015 | 10 | Bone pain |
| 92140155 | 9214015 | 11 | Antifungal prophylaxis |
| 92140155 | 9214015 | 12 | Antiviral prophylaxis |
| 92140155 | 9214015 | 13 | Thrombosis prophylaxis |
| 92140155 | 9214015 | 14 | Osteolysis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 92140155 | 9214015 | DE |
| 92140155 | 9214015 | HO |
| 92140155 | 9214015 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 92140155 | 9214015 | Febrile neutropenia | |
| 92140155 | 9214015 | Neutrophil count decreased | |
| 92140155 | 9214015 | Plasma cell myeloma | |
| 92140155 | 9214015 | Platelet count decreased | |
| 92140155 | 9214015 | Pneumonia | |
| 92140155 | 9214015 | Transaminases increased |
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 |
|---|---|---|---|---|---|---|
| 92140155 | 9214015 | 1 | 20130212 | 20130227 | 0 | |
| 92140155 | 9214015 | 2 | 20130308 | 20130312 | 0 | |
| 92140155 | 9214015 | 3 | 20130409 | 0 | ||
| 92140155 | 9214015 | 4 | 20130212 | 20130214 | 0 | |
| 92140155 | 9214015 | 5 | 20130312 | 0 | ||
| 92140155 | 9214015 | 6 | 20130409 | 0 | ||
| 92140155 | 9214015 | 7 | 20130212 | 20130227 | 0 | |
| 92140155 | 9214015 | 10 | 20121128 | 20130227 | 0 | |
| 92140155 | 9214015 | 11 | 20130212 | 0 | ||
| 92140155 | 9214015 | 12 | 20130212 | 0 | ||
| 92140155 | 9214015 | 13 | 20130212 | 20130227 | 0 | |
| 92140155 | 9214015 | 14 | 20120428 | 0 |