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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4331384 | 4120754 | F | 1 | 4331384-0 | 20040216 | 20040319 | 20040331 | EXP | JP-JNJFOC-20040301708 | CENTOCOR, INC. | 67 | YR | M | N | 55 | KG | 20040330 | MD | 20040306 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4331384 | 1004759734 | PS | REMICADE | 1 | INTRAVENOUS DRIP | SEE IMAGE | D | D | |||
| 4331384 | 1004770672 | SS | RHEUMATREX | 1 | ORAL | SEE IMAGE | |||||
| 4331384 | 1004770673 | C | HYPEN (ETODOLAC) TABLETS | 2 | |||||||
| 4331384 | 1004770674 | C | ONEALPHA (ALFACALCIDOL) TABLETS | 2 | |||||||
| 4331384 | 1004770676 | C | CYTOTEC (MISOPROSTOL) TABLETS | 2 | |||||||
| 4331384 | 1004770677 | C | OMEPRAL (OMEPRAZOLE) TABLETS | 2 | |||||||
| 4331384 | 1004770678 | C | TINELAC (SENNOSIDE A+B) TABLETS | 2 | |||||||
| 4331384 | 1004770679 | C | METHYCOBAL (MECOBALAMIN) TABLETS | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4331384 | 1004759734 | RHEUMATOID ARTHRITIS |
| 4331384 | 1004770672 | RHEUMATOID ARTHRITIS |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4331384 | DE |
| 4331384 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 4331384 | BLOOD LACTATE DEHYDROGENASE INCREASED |
| 4331384 | DRUG INTERACTION |
| 4331384 | HAEMATOCRIT DECREASED |
| 4331384 | HAEMOGLOBIN DECREASED |
| 4331384 | INTERSTITIAL LUNG DISEASE |
| 4331384 | PNEUMONIA |
| 4331384 | PNEUMONIA PRIMARY ATYPICAL |
| 4331384 | PRODUCTIVE COUGH |
| 4331384 | PYREXIA |
| 4331384 | RESPIRATORY FAILURE |
| 4331384 | WHITE BLOOD CELL COUNT INCREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4331384 | FGN |
| 4331384 | HP |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4331384 | 1004759734 | 20031204 | 20031204 | ||
| 4331384 | 1004759734 | 20031218 | 20031218 | ||
| 4331384 | 1004759734 | 20040114 | 20040114 | ||
| 4331384 | 1004770672 | 19970804 | 19980901 | ||
| 4331384 | 1004770672 | 19981001 | 19990801 | ||
| 4331384 | 1004770672 | 19990801 | 20021001 | ||
| 4331384 | 1004770672 | 20021001 | 20031001 | ||
| 4331384 | 1004770672 | 20031001 | 20031101 | ||
| 4331384 | 1004770672 | 20031203 | 20040212 |