Created at Source Raw Value Validated value
Aug. 17, 2021, 8:30 p.m. eu

Master Protocol Number 1.1 dated 07 April 2021: Part A, moderate disease: Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10) within 14 days. Part B, severe disease: Occurrence of death within 60 days. Baricitinib specific protocol v. 1.1 dated 07 April 2021: Occurrence of death within 60 days Master Protocol Number 1.1 dated 07 April 2021: Endpoint primario della Parte A della Fase 3: Malattia moderata Incidenza della progressione di malattia definita come progressione dallo stato moderato (WHO score 4-5) a severo (WHO score 6-9) o decesso (WHO score 6-9) nei 14 giorni dall’inizio del trattamento. Endpoint primario della Parte B della Fase 3: Malattia severa Tasso di mortalità nei 60 giorni successivi all’inizio del trattamento Baricitinib specific protocol v. 1.1 dated 07 April 2021: Mortalità entro 60 giorni dall’inizio del trattamento

Master Protocol Number 1.1 dated 07 April 2021: Part A, moderate disease: Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10) within 14 days. Part B, severe disease: Occurrence of death within 60 days. Baricitinib specific protocol v. 1.1 dated 07 April 2021: Occurrence of death within 60 days Master Protocol Number 1.1 dated 07 April 2021: Endpoint primario della Parte A della Fase 3: Malattia moderata Incidenza della progressione di malattia definita come progressione dallo stato moderato (WHO score 4-5) a severo (WHO score 6-9) o decesso (WHO score 6-9) nei 14 giorni dall’inizio del trattamento. Endpoint primario della Parte B della Fase 3: Malattia severa Tasso di mortalità nei 60 giorni successivi all’inizio del trattamento Baricitinib specific protocol v. 1.1 dated 07 April 2021: Mortalità entro 60 giorni dall’inizio del trattamento