Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Non-quinolone antibiotic · 1 trial · 1 indication
Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.
| Arm | Type | Description |
|---|---|---|
| Ciprofloxacin | EXPERIMENTAL | Subjects receiving Ciprofloxacin (group followed-up for 5 years) |
| Non-quinolone antibiotic | ACTIVE_COMPARATOR | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) |
| Name | Type | Description |
|---|---|---|
| Ciprofloxacin | DRUG | Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label |
| Non-quinolone antibiotic | DRUG | Common used dose and route |
Inclusion Criteria: * Patient is \>/= 2 months of age through 16 years of age * A parent/caregiver must sign an informed consent * Patient must provide assent, as appropriate based on local institutional review board guidelines Exclusion Criteria: * Patients presenting with the following conditio...
The non-quinolone antibiotic is a small molecule being developed for infectious diseases. It is currently in Phase 3 clinical development. The drug is being studied for use in pediatric patients with infectious diseases, as part of a clinical trial that has been completed.
The non-quinolone antibiotic is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is conducting clinical research on this small molecule for infectious disease indications, with the drug currently in Phase 3 development.
The non-quinolone antibiotic is in Phase 3 clinical development. It is an investigational small molecule being studied for infectious diseases. The drug has completed a Phase 3 trial, and it remains in clinical development as an investigational agent.
The non-quinolone antibiotic has one completed Phase 3 clinical trial, identified as NCT00761462, titled "BAY 0 9867 Cipro Pediatric Use Study (QUIP)". This trial enrolled 1029 participants in the United States and Canada, studying the drug in pediatric patients aged 2 months and older with infectious diseases.
The non-quinolone antibiotic is associated with the investigational compound BAY 0 9867, as referenced in the clinical trial NCT00761462. The trial is titled "BAY 0 9867 Cipro Pediatric Use Study (QUIP)", indicating that BAY 0 9867 is the drug being studied for infectious diseases in pediatric patients.