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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124278343 | 12427834 | 3 | F | 20160628 | 20160602 | 20160704 | EXP | SK-ROCHE-1768123 | ROCHE | 0.00 | F | Y | 44.10000 | KG | 20160704 | MD | SK | SK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124278343 | 12427834 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 375 | MG/M**2 | |||||||||
| 124278343 | 12427834 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 50722 | |||||||||||
| 124278343 | 12427834 | 3 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 50722 | |||||||||||
| 124278343 | 12427834 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | FEBRUARY-MARCH/2016 RESTARTED | 50722 | ||||||||||
| 124278343 | 12427834 | 5 | C | IVIG | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | START JAN- APR/2016 2 G/KG 2-4 WEEK ?STOP MAY/2016 | 0 | ||||||||||
| 124278343 | 12427834 | 6 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | 0 | TABLET | BID | |||||||||
| 124278343 | 12427834 | 7 | C | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | 0 | TABLET | BID | |||||||||
| 124278343 | 12427834 | 8 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 0 | TABLET | ||||||||||
| 124278343 | 12427834 | 9 | C | PIRAMIL | RAMIPRIL | 1 | Unknown | 0 | TABLET | QD | |||||||||
| 124278343 | 12427834 | 10 | C | VALSARTAN. | VALSARTAN | 1 | Unknown | 0 | TABLET | QD | |||||||||
| 124278343 | 12427834 | 11 | C | LUSOPRESS | NITRENDIPINE | 1 | Unknown | 0 | TABLET | ||||||||||
| 124278343 | 12427834 | 12 | C | OMEPRAZOL | OMEPRAZOLE | 1 | Unknown | 0 | TABLET | QD | |||||||||
| 124278343 | 12427834 | 13 | C | ROCALTROL | CALCITRIOL | 1 | Unknown | 0 | TABLET | QD | |||||||||
| 124278343 | 12427834 | 14 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 1/2 TABLET | 0 | TABLET | QD | ||||||||
| 124278343 | 12427834 | 15 | C | VIGANTOL | 2 | Unknown | GTT 1 X 5 GTT | 0 | |||||||||||
| 124278343 | 12427834 | 16 | C | VITACALCIN | 2 | Unknown | 0 | TABLET | BID | ||||||||||
| 124278343 | 12427834 | 17 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | BID | ||||||||||
| 124278343 | 12427834 | 18 | C | NEORECORMON | ERYTHROPOIETIN | 1 | Unknown | 3000 IU/0.3 ML 3 WEEKLY | 0 | ||||||||||
| 124278343 | 12427834 | 19 | C | DICYNONE | ETHAMSYLATE | 1 | Intravenous (not otherwise specified) | 0 | Q3W | ||||||||||
| 124278343 | 12427834 | 20 | C | METHYLPREDNISOLON | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 124278343 | 12427834 | 21 | C | PREDNISON | PREDNISONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 124278343 | 12427834 | 22 | C | METHOTREXATE (METHOTREXATE SODIUM) | METHOTREXATE SODIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124278343 | 12427834 | 1 | Autoimmune pancytopenia |
| 124278343 | 12427834 | 2 | Anti-neutrophil cytoplasmic antibody positive vasculitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124278343 | 12427834 | DE |
| 124278343 | 12427834 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124278343 | 12427834 | Bone marrow toxicity | |
| 124278343 | 12427834 | Gastrointestinal disorder | |
| 124278343 | 12427834 | Neutrophil count decreased | |
| 124278343 | 12427834 | Off label use | |
| 124278343 | 12427834 | Platelet count decreased | |
| 124278343 | 12427834 | Pulmonary haemorrhage | |
| 124278343 | 12427834 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 124278343 | 12427834 | 1 | 20160518 | 20160518 | 0 | |
| 124278343 | 12427834 | 2 | 201511 | 201512 | 0 | |
| 124278343 | 12427834 | 3 | 201601 | 0 | ||
| 124278343 | 12427834 | 4 | 201605 | 0 | ||
| 124278343 | 12427834 | 20 | 201508 | 201605 | 0 | |
| 124278343 | 12427834 | 21 | 201508 | 201605 | 0 | |
| 124278343 | 12427834 | 22 | 201601 | 201604 | 0 |