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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124640053 | 12464005 | 3 | F | 2014 | 20160606 | 20160614 | 20160720 | EXP | AM-JNJFOC-20160604439 | JANSSEN | 59.27 | YR | A | M | Y | 73.00000 | KG | 20160720 | MD | AM | AM |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124640053 | 12464005 | 1 | SS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | Y | 0 | TABLET | ||||||||
| 124640053 | 12464005 | 2 | SS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | Y | 0 | TABLET | ||||||||
| 124640053 | 12464005 | 3 | SS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | Y | 0 | TABLET | ||||||||
| 124640053 | 12464005 | 4 | PS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | Y | 204384 | TABLET | ||||||||
| 124640053 | 12464005 | 5 | SS | CYCLOSERINE. | CYCLOSERINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124640053 | 12464005 | 6 | SS | CYCLOSERINE. | CYCLOSERINE | 1 | Unknown | DOSE: 750 | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 7 | SS | AMOXICILLIN/CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124640053 | 12464005 | 8 | SS | AMOXICILLIN/CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | DOSE: 2000 | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 9 | SS | CLOFAZIMINE | CLOFAZIMINE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 10 | SS | CLOFAZIMINE | CLOFAZIMINE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 11 | SS | CLOFAZIMINE | CLOFAZIMINE | 1 | Unknown | DOSE: 100 | Y | 0 | UNSPECIFIED | ||||||||
| 124640053 | 12464005 | 12 | SS | LINEZOLID. | LINEZOLID | 1 | Unknown | DOSE: 600 | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 13 | SS | IMIPENEM | IMIPENEM | 1 | Unknown | DOSE: 600 | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 14 | SS | VITAMIN B6 | PYRIDOXINE HYDROCHLORIDE | 1 | Unknown | 0 | 200 | MG | UNSPECIFIED | ||||||||
| 124640053 | 12464005 | 15 | SS | PARA-AMINOSALICYLIC ACID | AMINOSALICYLIC ACID | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 16 | SS | PARA-AMINOSALICYLIC ACID | AMINOSALICYLIC ACID | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 124640053 | 12464005 | 17 | C | DIGOXIN. | DIGOXIN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124640053 | 12464005 | 1 | Tuberculosis |
| 124640053 | 12464005 | 2 | Tuberculosis |
| 124640053 | 12464005 | 3 | Tuberculosis |
| 124640053 | 12464005 | 4 | Tuberculosis |
| 124640053 | 12464005 | 5 | Tuberculosis |
| 124640053 | 12464005 | 6 | Tuberculosis |
| 124640053 | 12464005 | 7 | Tuberculosis |
| 124640053 | 12464005 | 8 | Tuberculosis |
| 124640053 | 12464005 | 9 | Tuberculosis |
| 124640053 | 12464005 | 10 | Tuberculosis |
| 124640053 | 12464005 | 11 | Tuberculosis |
| 124640053 | 12464005 | 12 | Tuberculosis |
| 124640053 | 12464005 | 13 | Tuberculosis |
| 124640053 | 12464005 | 14 | Prophylaxis |
| 124640053 | 12464005 | 15 | Tuberculosis |
| 124640053 | 12464005 | 16 | Tuberculosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124640053 | 12464005 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124640053 | 12464005 | Cardiopulmonary failure | |
| 124640053 | 12464005 | Dyspnoea | |
| 124640053 | 12464005 | Electrocardiogram QT prolonged | Electrocardiogram QT prolonged |
| 124640053 | 12464005 | Gastrointestinal carcinoma | |
| 124640053 | 12464005 | Intestinal obstruction | |
| 124640053 | 12464005 | Oedema peripheral | |
| 124640053 | 12464005 | Right ventricular failure |
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 |
|---|---|---|---|---|---|---|
| 124640053 | 12464005 | 1 | 20140910 | 0 | ||
| 124640053 | 12464005 | 2 | 20140428 | 20140620 | 0 | |
| 124640053 | 12464005 | 3 | 20140226 | 20140423 | 0 | |
| 124640053 | 12464005 | 4 | 20140702 | 0 | ||
| 124640053 | 12464005 | 6 | 20140226 | 0 | ||
| 124640053 | 12464005 | 8 | 20140226 | 0 | ||
| 124640053 | 12464005 | 9 | 20140707 | 0 | ||
| 124640053 | 12464005 | 11 | 20140226 | 20140620 | 0 | |
| 124640053 | 12464005 | 12 | 20140226 | 0 | ||
| 124640053 | 12464005 | 13 | 20140226 | 0 | ||
| 124640053 | 12464005 | 14 | 20140226 | 0 | ||
| 124640053 | 12464005 | 15 | 20140226 | 201409 | 0 |