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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111892214 | 11189221 | 4 | F | 20141129 | 20160829 | 20150615 | 20160905 | EXP | JP-JNJFOC-20150603312 | JANSSEN | 44.02 | YR | A | F | Y | 47.00000 | KG | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111892214 | 11189221 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 111892214 | 11189221 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 0 | 400 | MG | UNSPECIFIED | QD | |||||||
| 111892214 | 11189221 | 3 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .85 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 4 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.25 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 5 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .85 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 6 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 7 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 8 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.25 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 9 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 10 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .85 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 11 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.25 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 12 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | .85 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 13 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.25 | UG/KG | INJECTION | /wk | ||||||
| 111892214 | 11189221 | 14 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 0 | 300 | MG | TABLET | QD | |||||||
| 111892214 | 11189221 | 15 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 16 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 17 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 18 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 19 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 20 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 21 | C | LOCOID | HYDROCORTISONE BUTYRATE | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 22 | C | LOCOID | HYDROCORTISONE BUTYRATE | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 23 | C | LOCOID | HYDROCORTISONE BUTYRATE | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 24 | C | OXAROL | MAXACALCITOL | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 25 | C | OXAROL | MAXACALCITOL | 1 | Topical | 0 | OINTMENT | ||||||||||
| 111892214 | 11189221 | 26 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 111892214 | 11189221 | 27 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 111892214 | 11189221 | 28 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 5 MG ON AS NEEDED BASIS (P.R.N.) | 0 | 5 | MG | TABLET | |||||||
| 111892214 | 11189221 | 29 | C | KENALOG | TRIAMCINOLONE ACETONIDE | 1 | Topical | 5 MG ON AS NEEDED BASIS (P.R.N.) | 0 | OINTMENT |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111892214 | 11189221 | 1 | Chronic hepatitis C |
| 111892214 | 11189221 | 2 | Chronic hepatitis C |
| 111892214 | 11189221 | 3 | Chronic hepatitis C |
| 111892214 | 11189221 | 4 | Chronic hepatitis C |
| 111892214 | 11189221 | 5 | Chronic hepatitis C |
| 111892214 | 11189221 | 6 | Chronic hepatitis C |
| 111892214 | 11189221 | 7 | Chronic hepatitis C |
| 111892214 | 11189221 | 8 | Chronic hepatitis C |
| 111892214 | 11189221 | 9 | Chronic hepatitis C |
| 111892214 | 11189221 | 10 | Chronic hepatitis C |
| 111892214 | 11189221 | 11 | Chronic hepatitis C |
| 111892214 | 11189221 | 12 | Chronic hepatitis C |
| 111892214 | 11189221 | 13 | Chronic hepatitis C |
| 111892214 | 11189221 | 14 | Prophylaxis |
| 111892214 | 11189221 | 15 | Palmoplantar keratoderma |
| 111892214 | 11189221 | 16 | Palmoplantar keratoderma |
| 111892214 | 11189221 | 17 | Eczema asteatotic |
| 111892214 | 11189221 | 18 | Eczema asteatotic |
| 111892214 | 11189221 | 19 | Immune thrombocytopenic purpura |
| 111892214 | 11189221 | 20 | Immune thrombocytopenic purpura |
| 111892214 | 11189221 | 21 | Palmoplantar keratoderma |
| 111892214 | 11189221 | 22 | Eczema asteatotic |
| 111892214 | 11189221 | 23 | Immune thrombocytopenic purpura |
| 111892214 | 11189221 | 24 | Palmoplantar keratoderma |
| 111892214 | 11189221 | 25 | Immune thrombocytopenic purpura |
| 111892214 | 11189221 | 26 | Miliaria |
| 111892214 | 11189221 | 27 | Immune thrombocytopenic purpura |
| 111892214 | 11189221 | 28 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111892214 | 11189221 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111892214 | 11189221 | Blood bilirubin increased | |
| 111892214 | 11189221 | Platelet count decreased | |
| 111892214 | 11189221 | Pyrexia | |
| 111892214 | 11189221 | Sinusitis | |
| 111892214 | 11189221 | 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 |
|---|---|---|---|---|---|---|
| 111892214 | 11189221 | 1 | 20141129 | 20150221 | 0 | |
| 111892214 | 11189221 | 2 | 20141129 | 20150521 | 0 | |
| 111892214 | 11189221 | 3 | 20141205 | 20141205 | 0 | |
| 111892214 | 11189221 | 4 | 20141212 | 20141212 | 0 | |
| 111892214 | 11189221 | 5 | 20141219 | 20141219 | 0 | |
| 111892214 | 11189221 | 6 | 20150303 | 20150522 | 0 | |
| 111892214 | 11189221 | 7 | 20141129 | 20141129 | 0 | |
| 111892214 | 11189221 | 8 | 20141226 | 0 | ||
| 111892214 | 11189221 | 9 | 20150303 | 20150522 | 0 | |
| 111892214 | 11189221 | 10 | 20141219 | 20141219 | 0 | |
| 111892214 | 11189221 | 11 | 20141212 | 20141212 | 0 | |
| 111892214 | 11189221 | 12 | 20141205 | 20141205 | 0 | |
| 111892214 | 11189221 | 13 | 20141226 | 0 | ||
| 111892214 | 11189221 | 14 | 20150511 | 0 | ||
| 111892214 | 11189221 | 15 | 20141219 | 20150209 | 0 | |
| 111892214 | 11189221 | 16 | 20150210 | 20150522 | 0 | |
| 111892214 | 11189221 | 17 | 20150210 | 20150522 | 0 | |
| 111892214 | 11189221 | 18 | 20141219 | 20150209 | 0 | |
| 111892214 | 11189221 | 19 | 20150210 | 20150522 | 0 | |
| 111892214 | 11189221 | 20 | 20141219 | 20150209 | 0 | |
| 111892214 | 11189221 | 21 | 20141219 | 0 | ||
| 111892214 | 11189221 | 22 | 20141219 | 0 | ||
| 111892214 | 11189221 | 23 | 20141219 | 0 | ||
| 111892214 | 11189221 | 24 | 20141212 | 20150119 | 0 | |
| 111892214 | 11189221 | 25 | 20141212 | 20150119 | 0 | |
| 111892214 | 11189221 | 26 | 20141212 | 0 | ||
| 111892214 | 11189221 | 27 | 20141212 | 0 | ||
| 111892214 | 11189221 | 28 | 20141129 | 20141203 | 0 | |
| 111892214 | 11189221 | 29 | 20150324 | 0 |