Conditions: Osteoarthritis Cancer Pain Recurrent Low Back Pain
Keywords: Exposure in utero in tanezumab program
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.

Detailed description:
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063

Arms:
arm 1: Long term observational study of subjects from tanezumab parent study

Interventions: intervention 1: Investigational medical product (IMP) administered in parent study
Intervention descriptions: intervention 1: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study

Protocol document:
Prot_000.pdf: 























































































SAP_001.pdf: