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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117825093 | 11782509 | 3 | F | 20160808 | 20151127 | 20160811 | EXP | CA-ROCHE-1666990 | ROCHE | 68.00 | YR | F | Y | 62.00000 | KG | 20160811 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117825093 | 11782509 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 1 | DF | QD | |||||||
| 117825093 | 11782509 | 2 | SS | IRBESARTAN. | IRBESARTAN | 1 | Oral | U | 0 | 37.5 | MG | TABLET | QD | ||||||
| 117825093 | 11782509 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | THERAPY DURATION: 23 DAYS | U | 0 | 900 | MG | /wk | ||||||
| 117825093 | 11782509 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 1200 | MG | QOW | |||||||
| 117825093 | 11782509 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 6 | C | APO-SULFATRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 7 | C | BISOPROLOL | BISOPROLOL | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 8 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 9 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 10 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 11 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 12 | C | RAPAMUNE | SIROLIMUS | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 13 | C | RISEDRONATE SODIUM. | RISEDRONATE SODIUM | 1 | 0 | ||||||||||||
| 117825093 | 11782509 | 14 | C | SODIUM FLUORIDE. | SODIUM FLUORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117825093 | 11782509 | 1 | Prophylaxis against transplant rejection |
| 117825093 | 11782509 | 2 | Hypertension |
| 117825093 | 11782509 | 3 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117825093 | 11782509 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117825093 | 11782509 | Abdominal discomfort | |
| 117825093 | 11782509 | Abdominal distension | |
| 117825093 | 11782509 | Abdominal pain | |
| 117825093 | 11782509 | Aphonia | |
| 117825093 | 11782509 | Blood creatinine increased | |
| 117825093 | 11782509 | Blood disorder | |
| 117825093 | 11782509 | Blood iron decreased | |
| 117825093 | 11782509 | Blood lactate dehydrogenase increased | |
| 117825093 | 11782509 | Blood pressure decreased | |
| 117825093 | 11782509 | Chest discomfort | |
| 117825093 | 11782509 | Condition aggravated | |
| 117825093 | 11782509 | Cough | |
| 117825093 | 11782509 | Cytomegalovirus syndrome | |
| 117825093 | 11782509 | Diarrhoea | |
| 117825093 | 11782509 | Discomfort | |
| 117825093 | 11782509 | Dizziness | |
| 117825093 | 11782509 | Drug level increased | |
| 117825093 | 11782509 | Dysphonia | |
| 117825093 | 11782509 | Dyspnoea exertional | |
| 117825093 | 11782509 | Faeces soft | |
| 117825093 | 11782509 | Fatigue | |
| 117825093 | 11782509 | Fluid retention | |
| 117825093 | 11782509 | Gastroenteritis | |
| 117825093 | 11782509 | Haemoglobin decreased | |
| 117825093 | 11782509 | Haemorrhoidal haemorrhage | |
| 117825093 | 11782509 | Haemorrhoids | |
| 117825093 | 11782509 | Headache | |
| 117825093 | 11782509 | Hypotension | |
| 117825093 | 11782509 | Influenza | |
| 117825093 | 11782509 | Joint swelling | |
| 117825093 | 11782509 | Musculoskeletal stiffness | |
| 117825093 | 11782509 | Nasopharyngitis | |
| 117825093 | 11782509 | Nausea | |
| 117825093 | 11782509 | Oropharyngeal pain | |
| 117825093 | 11782509 | Peripheral swelling | |
| 117825093 | 11782509 | Pyrexia | |
| 117825093 | 11782509 | Red blood cell count decreased | |
| 117825093 | 11782509 | Rhinorrhoea | |
| 117825093 | 11782509 | Swelling face | |
| 117825093 | 11782509 | Viral infection | |
| 117825093 | 11782509 | Vomiting | |
| 117825093 | 11782509 | Weight increased | |
| 117825093 | 11782509 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |