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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123269646 | 12326964 | 6 | F | 20160404 | 20160815 | 20160503 | 20160819 | EXP | ZA-JNJFOC-20160414572 | JANSSEN | 35.28 | YR | A | F | Y | 59.00000 | KG | 20160819 | MD | ZA | ZA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123269646 | 12326964 | 1 | SS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | N | 0 | TABLET | ||||||||
| 123269646 | 12326964 | 2 | SS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | N | 0 | 200 | MG | TABLET | TIW | |||||
| 123269646 | 12326964 | 3 | SS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | N | 0 | 200 | MG | TABLET | TIW | |||||
| 123269646 | 12326964 | 4 | PS | SIRTURO | BEDAQUILINE FUMARATE | 1 | Oral | Y | N | 204384 | TABLET | ||||||||
| 123269646 | 12326964 | 5 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | Y | N | 0 | 1000 | MG | UNSPECIFIED | QD | |||||
| 123269646 | 12326964 | 6 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | Y | N | 20634 | UNSPECIFIED | ||||||||
| 123269646 | 12326964 | 7 | SS | DELAMANID | DELAMANID | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 123269646 | 12326964 | 8 | SS | DELAMANID | DELAMANID | 1 | Oral | Y | 0 | 100 | MG | UNSPECIFIED | BID | ||||||
| 123269646 | 12326964 | 9 | SS | LINEZOLID. | LINEZOLID | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 123269646 | 12326964 | 10 | SS | LINEZOLID. | LINEZOLID | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 123269646 | 12326964 | 11 | SS | PYRAZINAMIDE. | PYRAZINAMIDE | 1 | Oral | Y | 0 | 1750 | MG | UNSPECIFIED | QD | ||||||
| 123269646 | 12326964 | 12 | SS | PYRAZINAMIDE. | PYRAZINAMIDE | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 123269646 | 12326964 | 13 | SS | TERIZIDONE | TERIZIDONE | 1 | Oral | Y | 0 | 750 | MG | UNSPECIFIED | QD | ||||||
| 123269646 | 12326964 | 14 | SS | TERIZIDONE | TERIZIDONE | 1 | Oral | Y | 0 | 750 | MG | UNSPECIFIED | QD | ||||||
| 123269646 | 12326964 | 15 | SS | ISONIAZID. | ISONIAZID | 1 | Oral | Y | 0 | 300 | MG | UNSPECIFIED | QD | ||||||
| 123269646 | 12326964 | 16 | SS | ISONIAZID. | ISONIAZID | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 123269646 | 12326964 | 17 | C | EPILEM | EPIRUBICIN HYDROCHLORIDE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 123269646 | 12326964 | 18 | C | EPILEM | EPIRUBICIN HYDROCHLORIDE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 123269646 | 12326964 | 19 | C | LAMIVUDINE W/NEVIRAPINE/TENOFOVIR DISOPROXIL | 2 | Unknown | 0 | UNKNOWN | |||||||||||
| 123269646 | 12326964 | 20 | C | NEVIRAPINE. | NEVIRAPINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123269646 | 12326964 | 1 | Epilepsy |
| 123269646 | 12326964 | 2 | Epilepsy |
| 123269646 | 12326964 | 3 | Tuberculosis |
| 123269646 | 12326964 | 4 | Tuberculosis |
| 123269646 | 12326964 | 5 | Tuberculosis |
| 123269646 | 12326964 | 6 | Tuberculosis |
| 123269646 | 12326964 | 7 | Tuberculosis |
| 123269646 | 12326964 | 8 | Tuberculosis |
| 123269646 | 12326964 | 9 | Tuberculosis |
| 123269646 | 12326964 | 10 | Tuberculosis |
| 123269646 | 12326964 | 11 | Tuberculosis |
| 123269646 | 12326964 | 12 | Tuberculosis |
| 123269646 | 12326964 | 13 | Tuberculosis |
| 123269646 | 12326964 | 14 | Tuberculosis |
| 123269646 | 12326964 | 15 | Tuberculosis |
| 123269646 | 12326964 | 16 | Tuberculosis |
| 123269646 | 12326964 | 17 | Epilepsy |
| 123269646 | 12326964 | 18 | Epilepsy |
| 123269646 | 12326964 | 19 | HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123269646 | 12326964 | OT |
| 123269646 | 12326964 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123269646 | 12326964 | Alanine aminotransferase increased | |
| 123269646 | 12326964 | Anaemia | |
| 123269646 | 12326964 | Blood creatinine increased | |
| 123269646 | 12326964 | Chest pain | |
| 123269646 | 12326964 | Confusional state | |
| 123269646 | 12326964 | Gastroenteritis | |
| 123269646 | 12326964 | Haematemesis | |
| 123269646 | 12326964 | Headache | |
| 123269646 | 12326964 | Hypoalbuminaemia | |
| 123269646 | 12326964 | Hypokalaemia | |
| 123269646 | 12326964 | Hypomagnesaemia | |
| 123269646 | 12326964 | Hyponatraemia | |
| 123269646 | 12326964 | Hypothyroidism | |
| 123269646 | 12326964 | Pain | |
| 123269646 | 12326964 | Photophobia | |
| 123269646 | 12326964 | Platelet count decreased | |
| 123269646 | 12326964 | Psychotic disorder | |
| 123269646 | 12326964 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 123269646 | 12326964 | 1 | 20160418 | 0 | ||
| 123269646 | 12326964 | 2 | 20160316 | 20160413 | 0 | |
| 123269646 | 12326964 | 3 | 20160316 | 20160413 | 0 | |
| 123269646 | 12326964 | 4 | 20160418 | 0 | ||
| 123269646 | 12326964 | 5 | 20160316 | 20160413 | 0 | |
| 123269646 | 12326964 | 6 | 20160418 | 0 | ||
| 123269646 | 12326964 | 7 | 20160418 | 0 | ||
| 123269646 | 12326964 | 8 | 20160316 | 20160413 | 0 | |
| 123269646 | 12326964 | 9 | 20160418 | 0 | ||
| 123269646 | 12326964 | 10 | 20160316 | 20160413 | 0 | |
| 123269646 | 12326964 | 11 | 20150528 | 20160413 | 0 | |
| 123269646 | 12326964 | 12 | 20160418 | 0 | ||
| 123269646 | 12326964 | 13 | 20150528 | 20160413 | 0 | |
| 123269646 | 12326964 | 14 | 20160418 | 20160426 | 0 | |
| 123269646 | 12326964 | 15 | 20150528 | 20160413 | 0 | |
| 123269646 | 12326964 | 16 | 20160418 | 0 | ||
| 123269646 | 12326964 | 17 | 201603 | 0 | ||
| 123269646 | 12326964 | 18 | 20160415 | 0 | ||
| 123269646 | 12326964 | 19 | 20160316 | 0 |