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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125275481 | 12527548 | 1 | I | 20151015 | 20160624 | 20160705 | 20160705 | EXP | US-ROCHE-1783222 | ROCHE | 31.95 | YR | F | Y | 66.20000 | KG | 20160705 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125275481 | 12527548 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 2000 | MG | QD | |||||||
| 125275481 | 12527548 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 1500 | MG | BID | |||||||
| 125275481 | 12527548 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 1000 | MG | BID | |||||||
| 125275481 | 12527548 | 4 | SS | BERAPROST SODIUM | BERAPROST SODIUM | 1 | Unknown | U | 0 | 30 | UG | QD | |||||||
| 125275481 | 12527548 | 5 | SS | BERAPROST SODIUM | BERAPROST SODIUM | 1 | Unknown | U | 0 | QID | |||||||||
| 125275481 | 12527548 | 6 | SS | TYVASO | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | INHALATIONAL GAS 0.6 MG/ML 18-72 MCG | Y | 2100687 | 0 | 18 | UG | QID | |||||
| 125275481 | 12527548 | 7 | SS | TYVASO | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | INHALATIONAL | Y | 2100687 | 0 | 288 | UG | ||||||
| 125275481 | 12527548 | 8 | C | ADCIRCA | TADALAFIL | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 125275481 | 12527548 | 9 | C | LETAIRIS | AMBRISENTAN | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 125275481 | 12527548 | 10 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 125275481 | 12527548 | 11 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 0 | 400 | MG | QD | ||||||||
| 125275481 | 12527548 | 12 | C | XARELTO | RIVAROXABAN | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 125275481 | 12527548 | 13 | C | CLARITIN | LORATADINE | 1 | 0 | ||||||||||||
| 125275481 | 12527548 | 14 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125275481 | 12527548 | 15 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | AS NEEDED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125275481 | 12527548 | 1 | Systemic lupus erythematosus |
| 125275481 | 12527548 | 4 | Pulmonary arterial hypertension |
| 125275481 | 12527548 | 6 | Hypertension |
| 125275481 | 12527548 | 8 | Pulmonary arterial hypertension |
| 125275481 | 12527548 | 9 | Pulmonary arterial hypertension |
| 125275481 | 12527548 | 10 | Pulmonary arterial hypertension |
| 125275481 | 12527548 | 11 | Systemic lupus erythematosus |
| 125275481 | 12527548 | 12 | Pulmonary embolism |
| 125275481 | 12527548 | 13 | Hypersensitivity |
| 125275481 | 12527548 | 14 | Infusion site pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125275481 | 12527548 | HO |
| 125275481 | 12527548 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125275481 | 12527548 | Bacterial vaginosis | |
| 125275481 | 12527548 | Neutropenia | |
| 125275481 | 12527548 | Pulmonary function test decreased | |
| 125275481 | 12527548 | Pulmonary hypertension | |
| 125275481 | 12527548 | Supraventricular tachycardia |
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 |
|---|---|---|---|---|---|---|
| 125275481 | 12527548 | 1 | 20110608 | 0 | ||
| 125275481 | 12527548 | 5 | 20151015 | 0 | ||
| 125275481 | 12527548 | 6 | 20150326 | 0 | ||
| 125275481 | 12527548 | 7 | 20151026 | 0 | ||
| 125275481 | 12527548 | 8 | 20110501 | 0 | ||
| 125275481 | 12527548 | 9 | 20110910 | 0 |