Votrient Liver Data Meta-analysis (200276)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Meta-analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PAZOPANIB

Population studied

• Short description of the study population:
  Patients from US suffering from pazopanib-induced liver toxicity.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  2080

Study design details

• Main study objective:
  To characterize pazopanib-induced liver toxicity and to explore potential predictive and/or prognostic factors for pazopanib-induced liver events and risk factors for rechallenge failure.
• Data analysis plan:
  Data will be summarised by indication and also by the peak ALT level during the first ALT elevation >3xULN (>3-5xULN, >5-8xULN, >8-20xULN and >20xULN). This is defined as the peak ALT value from the initial elevation >3xULN until recovery. Recovery is defined as ALT returning to 2.5xULN or below for two consecutive tests or dropping to 2.5xULN or below once after study treatment discontinuation with no further data available. Recovery also includes those cases where dose was interrupted after an ALT>3xULN event, then ALT returned to 2.5xULN or below with only one test and subject was re-challenged before their next ALT test.

Documents

Study results

gsk-200276-clinical-study-report-redact