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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126772701 | 12677270 | 1 | I | 20160816 | 20160823 | 20160823 | EXP | FR-JNJFOC-20160813257 | JANSSEN | PIPERNO-NEUMANN S, DELEY ML, REDINI F, PACQUEMENT H, MAREC-BERARD P, PETIT P, ET AL. ZOLEDRONATE IN COMBINATION WITH CHEMOTHERAPY AND SURGERY TO TREAT OSTEOSARCOMA (OS2006): A RANDOMISED, MULTICENTRE, OPEN-LABEL, PHASE 3 TRIAL. LANCET ONCOL 2016;17/8:1070-80. | 0.00 | A | Y | 0.00000 | 20160823 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126772701 | 12677270 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 75 MG/M2 IN PATIENTS WITH POOR HISTOLOGICAL RESPONSE | U | U | 50718 | LIPOSOME INJECTION | |||||||
| 126772701 | 12677270 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | U | 0 | UNSPECIFIED | ||||||||||
| 126772701 | 12677270 | 3 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 126772701 | 12677270 | 4 | SS | ZOLEDRONATE | ZOLEDRONIC ACID | 1 | Unknown | U | 0 | 4 | MG | UNSPECIFIED | |||||||
| 126772701 | 12677270 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126772701 | 12677270 | 1 | Osteosarcoma |
| 126772701 | 12677270 | 2 | Osteosarcoma |
| 126772701 | 12677270 | 3 | Osteosarcoma |
| 126772701 | 12677270 | 4 | Osteosarcoma |
| 126772701 | 12677270 | 5 | Osteosarcoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126772701 | 12677270 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126772701 | 12677270 | Alanine aminotransferase increased | |
| 126772701 | 12677270 | Anaemia | |
| 126772701 | 12677270 | Angiopathy | |
| 126772701 | 12677270 | Aspartate aminotransferase increased | |
| 126772701 | 12677270 | Blood bilirubin increased | |
| 126772701 | 12677270 | Blood creatinine increased | |
| 126772701 | 12677270 | Cardiotoxicity | |
| 126772701 | 12677270 | Cystitis | |
| 126772701 | 12677270 | Endocrine toxicity | |
| 126772701 | 12677270 | Febrile neutropenia | |
| 126772701 | 12677270 | Fracture | |
| 126772701 | 12677270 | Gastrointestinal disorder | |
| 126772701 | 12677270 | Genitourinary symptom | |
| 126772701 | 12677270 | Haemorrhage | |
| 126772701 | 12677270 | Headache | |
| 126772701 | 12677270 | Hypersensitivity | |
| 126772701 | 12677270 | Hypocalcaemia | |
| 126772701 | 12677270 | Hypophosphataemia | |
| 126772701 | 12677270 | Infection | |
| 126772701 | 12677270 | Mood altered | |
| 126772701 | 12677270 | Mucosal inflammation | |
| 126772701 | 12677270 | Musculoskeletal disorder | |
| 126772701 | 12677270 | Neuropathy peripheral | |
| 126772701 | 12677270 | Neurotoxicity | |
| 126772701 | 12677270 | Neutropenia | |
| 126772701 | 12677270 | Nonspecific reaction | |
| 126772701 | 12677270 | Ocular toxicity | |
| 126772701 | 12677270 | Ototoxicity | |
| 126772701 | 12677270 | Pulmonary toxicity | |
| 126772701 | 12677270 | Pyrexia | |
| 126772701 | 12677270 | Renal disorder | |
| 126772701 | 12677270 | Sexual dysfunction | |
| 126772701 | 12677270 | Skin toxicity | |
| 126772701 | 12677270 | Thrombocytopenia | |
| 126772701 | 12677270 | Weight decreased | |
| 126772701 | 12677270 | Wound complication |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |