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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121281674 | 12128167 | 4 | F | 20160211 | 20160704 | 20160229 | 20160711 | EXP | FR-SA-2016SA040324 | AVENTIS | 7.00 | MON | I | M | Y | 7.00000 | KG | 20160711 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121281674 | 12128167 | 1 | PS | CAMPATH | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | F3011H11 | 103948 | 3.6 | MG | QD | ||||||
| 121281674 | 12128167 | 2 | SS | CAMPATH | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 103948 | 7.2 | MG | QD | ||||||
| 121281674 | 12128167 | 3 | SS | CAMPATH | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 103948 | 7.5 | MG | QD | ||||||
| 121281674 | 12128167 | 4 | SS | CAMPATH | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 103948 | |||||||||
| 121281674 | 12128167 | 5 | C | ORACILLINE | PENICILLIN V | 1 | Oral | DOSE:0.5 | 0 | ||||||||||
| 121281674 | 12128167 | 6 | C | DEXCHLORPHENIRAMINE | DEXCHLORPHENIRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | QD | ||||||||
| 121281674 | 12128167 | 7 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 15 | MG | |||||||||
| 121281674 | 12128167 | 8 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Oral | 0 | 80 | MG | |||||||||
| 121281674 | 12128167 | 9 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | DOSE: 100 | 0 | ||||||||||
| 121281674 | 12128167 | 10 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | 200 | MG | TIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121281674 | 12128167 | 1 | Histiocytosis haematophagic |
| 121281674 | 12128167 | 2 | Histiocytosis haematophagic |
| 121281674 | 12128167 | 3 | Histiocytosis haematophagic |
| 121281674 | 12128167 | 4 | Histiocytosis haematophagic |
| 121281674 | 12128167 | 5 | Prophylaxis |
| 121281674 | 12128167 | 6 | Premedication |
| 121281674 | 12128167 | 7 | Premedication |
| 121281674 | 12128167 | 8 | Premedication |
| 121281674 | 12128167 | 9 | Premedication |
| 121281674 | 12128167 | 10 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121281674 | 12128167 | OT |
| 121281674 | 12128167 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121281674 | 12128167 | Brain oedema | |
| 121281674 | 12128167 | Capillary nail refill test | |
| 121281674 | 12128167 | Chills | |
| 121281674 | 12128167 | Condition aggravated | |
| 121281674 | 12128167 | Cytokine release syndrome | |
| 121281674 | 12128167 | Haemodynamic instability | |
| 121281674 | 12128167 | Hepatocellular injury | |
| 121281674 | 12128167 | Hyponatraemia | |
| 121281674 | 12128167 | Livedo reticularis | |
| 121281674 | 12128167 | Peripheral coldness | |
| 121281674 | 12128167 | Pyrexia | |
| 121281674 | 12128167 | Rash | |
| 121281674 | 12128167 | Seizure | |
| 121281674 | 12128167 | Tachycardia | |
| 121281674 | 12128167 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 121281674 | 12128167 | 1 | 20160210 | 20160210 | 0 | |
| 121281674 | 12128167 | 2 | 20160211 | 20160211 | 0 | |
| 121281674 | 12128167 | 3 | 20160224 | 20160225 | 0 | |
| 121281674 | 12128167 | 5 | 20160201 | 20160212 | 0 | |
| 121281674 | 12128167 | 6 | 20160210 | 20160212 | 0 | |
| 121281674 | 12128167 | 7 | 20150224 | 0 | ||
| 121281674 | 12128167 | 8 | 20160107 | 0 | ||
| 121281674 | 12128167 | 9 | 20160210 | 20160217 | 0 | |
| 121281674 | 12128167 | 10 | 20160116 | 0 |