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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125297851 | 12529785 | 1 | I | 20160621 | 20160706 | 20160706 | EXP | GB-LUPIN PHARMACEUTICALS INC.-2016-02944 | LUPIN | LEWIS J, HINE P, WALKER J, KHOO S, TAEGTMEYER M, SQUIRE S, SQUIRE S. FIRST EXPERIENCE OF EFFECTIVENESS AND SAFETY OF BEDAQUILINE FOR 18 MONTHS WITHIN AN OPTIMISED REGIMEN FOR XDR-TB. EUROPEAN RESPIRATORY JOURNAL. 2016;. | 20.00 | YR | F | Y | 0.00000 | 20160706 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125297851 | 12529785 | 1 | PS | ETHAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 1 | Unknown | UNKNOWN | 78939 | ||||||||||
| 125297851 | 12529785 | 2 | SS | Rifampicin | RIFAMPIN | 1 | Unknown | UNKNOWN | 90034 | ||||||||||
| 125297851 | 12529785 | 3 | SS | ISONIAZID. | ISONIAZID | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 4 | SS | PYRAZINAMIDE. | PYRAZINAMIDE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 5 | SS | PYRAZINAMIDE. | PYRAZINAMIDE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 6 | SS | Prothionamide | PROTIONAMIDE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 7 | SS | LINEZOLID. | LINEZOLID | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 8 | SS | LINEZOLID. | LINEZOLID | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 9 | SS | PARA-AMINOSALICYLIC ACID | AMINOSALICYLIC ACID | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 10 | SS | PARA-AMINOSALICYLIC ACID | AMINOSALICYLIC ACID | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 11 | SS | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Unknown | UNKNOWN | 65398 | ||||||||||
| 125297851 | 12529785 | 12 | SS | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Unknown | UNKNOWN | 65398 | ||||||||||
| 125297851 | 12529785 | 13 | SS | Bedaquiline | BEDAQUILINE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125297851 | 12529785 | 14 | SS | Clofazimine | CLOFAZIMINE | 1 | Unknown | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125297851 | 12529785 | 1 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 2 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 3 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 4 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 6 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 7 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 9 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 11 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 13 | Pulmonary tuberculosis |
| 125297851 | 12529785 | 14 | Pulmonary tuberculosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125297851 | 12529785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125297851 | 12529785 | Drug resistance | |
| 125297851 | 12529785 | Electrocardiogram QT prolonged |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |