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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121029563 | 12102956 | 3 | F | 201511 | 20160623 | 20160222 | 20160701 | PER | US-CELGENEUS-USA-2016011490 | CELGENE | 62.16 | YR | F | Y | 33.60000 | KG | 20160701 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121029563 | 12102956 | 1 | PS | THALOMID | THALIDOMIDE | 1 | Oral | U | U | UNKNOWN | 20785 | 100 | MG | CAPSULES | QD | ||||
| 121029563 | 12102956 | 2 | SS | THALOMID | THALIDOMIDE | 1 | Oral | 200 MILLIGRAM | U | U | UNKNOWN | 20785 | 100 | MG | CAPSULES | ||||
| 121029563 | 12102956 | 3 | SS | THALOMID | THALIDOMIDE | 1 | U | U | UNKNOWN | 20785 | |||||||||
| 121029563 | 12102956 | 4 | C | Amiodarone | AMIODARONE | 1 | Unknown | 0 | 200 | MG | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121029563 | 12102956 | 1 | Gastrointestinal haemorrhage |
| 121029563 | 12102956 | 2 | Off label use |
| 121029563 | 12102956 | 3 | Arteriovenous malformation |
| 121029563 | 12102956 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121029563 | 12102956 | HO |
| 121029563 | 12102956 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121029563 | 12102956 | Gastrointestinal haemorrhage | |
| 121029563 | 12102956 | Haemoglobin decreased | |
| 121029563 | 12102956 | 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 |
|---|---|---|---|---|---|---|
| 121029563 | 12102956 | 1 | 201510 | 0 | ||
| 121029563 | 12102956 | 2 | 201511 | 0 | ||
| 121029563 | 12102956 | 4 | 20151207 | 0 |