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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126908511 | 12690851 | 1 | I | 20160816 | 20160826 | 20160826 | EXP | JP-CELGENEUS-JPN-2016084255 | CELGENE | MISAWA S. SAFETY AND EFFICACY OF THALIDOMIDE IN PATIENTS WITH POEMS SYNDROME: A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL.. LANCET NEUROL. 2016 AUG 02;1-9. | 0.00 | Y | 0.00000 | 20160826 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126908511 | 12690851 | 1 | PS | THALOMID | THALIDOMIDE | 1 | Oral | 200 MILLIGRAM | U | 20785 | 200 | MG | CAPSULES | QD | |||||
| 126908511 | 12690851 | 2 | SS | DEXAMETHASONE ORAL | DEXAMETHASONE | 1 | Oral | U | 0 | 12 | MG/M**2 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126908511 | 12690851 | 1 | POEMS syndrome |
| 126908511 | 12690851 | 2 | POEMS syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126908511 | 12690851 | OT |
| 126908511 | 12690851 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126908511 | 12690851 | Alanine aminotransferase increased | |
| 126908511 | 12690851 | Aspartate aminotransferase increased | |
| 126908511 | 12690851 | Cardiac arrest | |
| 126908511 | 12690851 | Cardiac failure | |
| 126908511 | 12690851 | Constipation | |
| 126908511 | 12690851 | Dehydration | |
| 126908511 | 12690851 | Dry skin | |
| 126908511 | 12690851 | Eosinophil count increased | |
| 126908511 | 12690851 | Hyperglycaemia | |
| 126908511 | 12690851 | Hyperkalaemia | |
| 126908511 | 12690851 | Hypertension | |
| 126908511 | 12690851 | Insomnia | |
| 126908511 | 12690851 | Neutrophil count decreased | |
| 126908511 | 12690851 | POEMS syndrome | |
| 126908511 | 12690851 | Peripheral sensory neuropathy | |
| 126908511 | 12690851 | Pyrexia | |
| 126908511 | 12690851 | Sinus bradycardia | |
| 126908511 | 12690851 | Somnolence | |
| 126908511 | 12690851 | Upper respiratory tract infection | |
| 126908511 | 12690851 | Urticaria | |
| 126908511 | 12690851 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |