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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6544552 | 7573271 | I | 6544552-4 | 20100107 | 20100120 | DIR | 5 | YR | M | N | 32.4 | KG | 20100119 | MD | Y | Y | UNITED STATES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6544552 | 1012973381 | PS | PEGINTRON 80MICROGRAM/0.5ML SCHERING CORPORATION | 2 | SUBCUTANEOUS | 0.4ML (64 MICROGRAMS) ONE DOSE SUBCUTANEOUS | Y | D | |||
| 6544552 | 1012985945 | SS | REBETOL | 1 | ORAL | 6 ML (240 MG) ONE DOSE ORAL | Y | D |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6544552 | 1012973381 | HEPATITIS C |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6544552 | HO |
| 6544552 | LT |
| 6544552 | RI |
Reactions reported
| Event ID | PT |
|---|---|
| 6544552 | ACUTE RESPIRATORY DISTRESS SYNDROME |
| 6544552 | ALANINE AMINOTRANSFERASE INCREASED |
| 6544552 | ASPARTATE AMINOTRANSFERASE INCREASED |
| 6544552 | BLOOD BILIRUBIN INCREASED |
| 6544552 | BLOOD CREATININE INCREASED |
| 6544552 | COMA |
| 6544552 | CONVULSION |
| 6544552 | DISSEMINATED INTRAVASCULAR COAGULATION |
| 6544552 | DYSKINESIA |
| 6544552 | ELECTROENCEPHALOGRAM ABNORMAL |
| 6544552 | ELECTROLYTE IMBALANCE |
| 6544552 | GENERALISED OEDEMA |
| 6544552 | HEADACHE |
| 6544552 | HYPOTENSION |
| 6544552 | INTERNATIONAL NORMALISED RATIO INCREASED |
| 6544552 | LACTIC ACIDOSIS |
| 6544552 | LIPASE INCREASED |
| 6544552 | MENTAL STATUS CHANGES |
| 6544552 | MITOCHONDRIAL TOXICITY |
| 6544552 | MULTI-ORGAN DISORDER |
| 6544552 | NEPHROGENIC DIABETES INSIPIDUS |
| 6544552 | PETECHIAE |
| 6544552 | PULMONARY OEDEMA |
| 6544552 | PYREXIA |
| 6544552 | RASH MACULO-PAPULAR |
| 6544552 | RESPIRATORY DISTRESS |
| 6544552 | SHOCK |
| 6544552 | TRANSAMINASES INCREASED |
| 6544552 | TREMOR |
| 6544552 | UNRESPONSIVE TO STIMULI |
| 6544552 | URINE OUTPUT INCREASED |
| 6544552 | URTICARIA |
| 6544552 | VOMITING |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6544552 | 1012973381 | 20100107 | |||
| 6544552 | 1012985945 | 20100107 |