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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126872521 | 12687252 | 1 | I | 20160812 | 20160826 | 20160826 | EXP | US-CIPLA LTD.-2016US17533 | CIPLA | KAKUDA TN, DEMASI R, VAN DELFT Y, MOHAMMED P.. PHARMACOKINETIC INTERACTION BETWEEN ETRAVIRINE OR DARUNAVIR/RITONAVIR AND ARTEMETHER/LUMEFANTRINE IN HEALTHY VOLUNTEERS: A TWO-PANEL, TWO-WAY, TWO-PERIOD, RANDOMIZED TRIAL. HIV MEDICINE. 2013;14:421 TO 429 | 0.00 | Y | 0.00000 | 20160826 | OT | US | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126872521 | 12687252 | 1 | PS | RITONAVIR. | RITONAVIR | 1 | Unknown | 100 MG, BID FROM DAY 1 TO DAY 21 | U | U | 0 | 100 | MG | BID | |||||
| 126872521 | 12687252 | 2 | SS | RITONAVIR. | RITONAVIR | 1 | Unknown | 100 MG, QD ON DAY 22 IN THE MORNING. | U | U | 0 | 100 | MG | QD | |||||
| 126872521 | 12687252 | 3 | SS | Darunavir | DARUNAVIR | 1 | Unknown | 600 MG, BID FROM DAY 1 TO DAY 21 | U | U | 0 | 600 | MG | BID | |||||
| 126872521 | 12687252 | 4 | SS | Darunavir | DARUNAVIR | 1 | Unknown | 600 MG, QD ON DAY 22 IN THE MORNING | U | U | 0 | 600 | MG | QD | |||||
| 126872521 | 12687252 | 5 | SS | ARTEMETHER/LUMEFANTRINE | ARTEMETHERLUMEFANTRINE | 1 | Unknown | 80/480 MG FOR 3 DAYS IN TREATMENT A | U | U | 0 | TABLET | |||||||
| 126872521 | 12687252 | 6 | SS | ARTEMETHER/LUMEFANTRINE | ARTEMETHERLUMEFANTRINE | 1 | Unknown | 80/480 MG FROM DAY 8 TO 11 IN TREATMENT B | U | U | 0 | TABLET |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126872521 | 12687252 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126872521 | 12687252 | Drug interaction | |
| 126872521 | 12687252 | 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 |