Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4465974 | 5664779 | I | 4465974-1 | 20040125 | 20040920 | 20040930 | EXP | STA-AE-04-MTX-425 | STADA PHARMACEUTICALS, INC. | 66 | YR | F | N | 20040920 |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4465974 | 1005265052 | PS | RHEUMATREX | 1 | ORAL | 8 MX 1X PER 1 WK, ORAL | D | D | 8085 | ||
| 4465974 | 1005287188 | SS | RHEUMATREX | 1 | ORAL | 2 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287204 | SS | RHEUMATREX | 1 | ORAL | 4 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287215 | SS | RHEUMATREX | 1 | ORAL | 6 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287222 | SS | RHEUMATREX | 1 | ORAL | 4 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287225 | SS | RHEUMATREX | 1 | ORAL | 6 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287226 | SS | RHEUMATREX | 1 | ORAL | 8 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287234 | SS | RHEUMATREX | 1 | ORAL | 4 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287239 | SS | RHEUMATREX | 1 | ORAL | 8 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287240 | SS | RHEUMATREX | 1 | ORAL | 4 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287245 | SS | RHEUMATREX | 1 | ORAL | 2 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287253 | SS | RHEUMATREX | 1 | ORAL | 4 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287261 | SS | RHEUMATREX | 1 | ORAL | 6 MG 1X PER 1 WK, ORAL | D | D | |||
| 4465974 | 1005287262 | SS | AZULFIDINE | 1 | ORAL | 1 G 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287283 | SS | FOLIC ACID | 1 | 5 MG 1X PER 1 WK | D | D | ||||
| 4465974 | 1005287288 | SS | LOXONIN (LOXOPROFEN SODIUM) | 2 | ORAL | 120 MG 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287294 | SS | PEON (ZALTOPROFEN) | 2 | ORAL | 16 G 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287296 | SS | PREDNISOLONE | 1 | ORAL | 7.5 MG 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287298 | SS | PREDNISOLONE | 1 | ORAL | 5 MG 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287302 | SS | PREDNISOLONE | 1 | ORAL | 10 MG 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287304 | SS | REMICADE | 1 | INTRAVENOUS | 3 MG/KG 1X PER 1 DAY, INTRAVENOUS | D | D | |||
| 4465974 | 1005287316 | SS | REMICADE | 1 | INTRAVENOUS | 3 MG/KG 1X PER 1 DAY, INTRAVENOUS | D | D | |||
| 4465974 | 1005287319 | SS | REMICADE | 1 | INTRAVENOUS | 3 MG/KG 1X PER 1 DAY, INTRAVENOUS | D | D | |||
| 4465974 | 1005287320 | SS | RIDAURA | 1 | ORAL | 3 MG 1X PER 1 DAY, ORAL | D | D | |||
| 4465974 | 1005287324 | SS | ZEPOLAS (FLURBIPROFEN) | 2 | TOPICAL | 6-7 SHEETS DAILY (TO) | D | D | |||
| 4465974 | 1005287326 | C | GASTER (FAMOTIDINE) | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4465974 | 1005265052 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287188 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287204 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287215 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287222 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287225 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287226 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287234 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287239 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287240 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287245 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287253 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287261 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287262 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287283 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287288 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287294 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287296 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287298 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287302 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287304 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287316 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287319 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287320 | RHEUMATOID ARTHRITIS |
| 4465974 | 1005287324 | RHEUMATOID ARTHRITIS |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4465974 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 4465974 | DISSEMINATED TUBERCULOSIS |
| 4465974 | HEPATIC STEATOSIS |
| 4465974 | LIVER ABSCESS |
| 4465974 | LIVER DISORDER |
| 4465974 | PYREXIA |
| 4465974 | RASH GENERALISED |
| 4465974 | SEPSIS |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4465974 | DT |
| 4465974 | FGN |
| 4465974 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4465974 | 1005265052 | 20031011 | 20040128 | ||
| 4465974 | 1005287188 | 19991222 | 20000913 | ||
| 4465974 | 1005287204 | 20000914 | 20010212 | ||
| 4465974 | 1005287215 | 20010213 | 20040924 | ||
| 4465974 | 1005287222 | 20010925 | 20011104 | ||
| 4465974 | 1005287225 | 20011105 | 20020120 | ||
| 4465974 | 1005287226 | 20020121 | 20020609 | ||
| 4465974 | 1005287234 | 20020610 | 20021117 | ||
| 4465974 | 1005287239 | 20021118 | 20021208 | ||
| 4465974 | 1005287240 | 20021209 | 20030430 | ||
| 4465974 | 1005287245 | 20030501 | 20030618 | ||
| 4465974 | 1005287253 | 20030619 | 20030912 | ||
| 4465974 | 1005287261 | 20030913 | 20031010 | ||
| 4465974 | 1005287262 | 20030619 | 20030813 | ||
| 4465974 | 1005287283 | 20030717 | 20040128 | ||
| 4465974 | 1005287288 | 20000815 | 20001101 | ||
| 4465974 | 1005287294 | 20001102 | 20040128 | ||
| 4465974 | 1005287296 | 19991222 | 20000402 | ||
| 4465974 | 1005287298 | 20020919 | |||
| 4465974 | 1005287302 | 20000403 | 20020918 | ||
| 4465974 | 1005287304 | 20031125 | 20031125 | ||
| 4465974 | 1005287316 | 20031212 | 20031212 | ||
| 4465974 | 1005287319 | 20040109 | 20040109 | ||
| 4465974 | 1005287320 | 20000914 | 20030415 | ||
| 4465974 | 1005287324 | 20020905 | 20040128 |