Populations for Analyses. All patients who receive at least 1 dose of ALXN2050 will be included in the safety and efficacy analyses.
Populations for Analyses. The following analysis populations are planned: Full Analysis Set All subjects who are randomized. Subjects will be classified according to the treatment assigned at randomization. The Full Analysis Set will be the primary population for evaluating all efficacy endpoints and subject characteristics. Per-protocol Analysis Set A subset of the Full Analysis Set and will include subjects who receive at least 1 dose of study treatment and do not have major protocol deviations expected to impact the primary objective of the study. Major protocol deviations will be pre-specified in the SAP. The Per-protocol Analysis Set will be used for sensitivity analyses for the primary efficacy endpoint. Safety Analysis Set All subjects who receive at least 1 dose of study treatment. Subjects will be classified according to the treatment assigned at randomization unless the incorrect treatment(s) are received throughout the dosing period, in which case subjects will be classified according to the first treatment received. The Safety Analysis Set will be the primary population for evaluating treatment administration/compliance and safety. PK Analysis Set All treated subjects who have at least 1 concentration above the limit of quantitation of the study treatment in RIST4721 arm only.
Populations for Analyses. The population sets used for analysis sets are defined in Table 6.
Populations for Analyses. The following study populations are defined and will be analyzed as specified below. All evaluable patients fit into the Safety dataset, among other datasets: The Intent to Treat (ITT) dataset: the total population of patients registered in the study. Safety dataset: all registered participants who received at least one Chemoplaque study intervention. Efficacy population: all enrolled patients who completed 42 days with at least one Chemoplaque and had adequate assessment of disease progression. Any patient who is registered on to this trial but never receives study treatment will be described, including the reason(s) for non-participation. All patients that receive a study dose will be included in all analyses. Any patient who is registered but never receives study treatment will be described, including the reason(s) for non-participation.
Populations for Analyses. The analysis populations will consist of subjects as defined below: • The Screened Analysis Set includes all subjects who are screened for the study. This population is used primarily for subject accounting purposes and will generally not be used for summary or analysis. • The Randomized Set includes all subjects who are randomized to receive study drug regardless of whether they take a dose. • The Safety Analysis Set includes all subjects who receive at least one dose of study drug. Subjects will be classified according to the treatment they actually receive. • The Full Analysis Set (FAS) includes all randomized IBS-D and IBS-M subjects who took at least one dose of double-blind study drug and had a baseline diary assessment and at least 1 post -randomization diary entry. Subjects will be analyzed according to randomized treatment, irrespective of whether or not they have prematurely discontinued, according to the Intent -to-Treat principle. The Full Analysis Set for IBS-D (FAS-D) and Full Analysis Set for IBS-M (FAS-M) are each a subset of FAS and consists of IBS-D and IBS-M subjects, respectively. The FAS-D will serve as the primary population for the primary analysis of efficacy data in this study. • The Per-Protocol Set for IBS-D excludes subjects from the FAS-D due to important deviations from the protocol that may substantially affect the result of the primary efficacy endpoint (ie, Major Protocol Deviations associated with efficacy). The Per -Protocol Set will serve as the supportive population for the analysis of efficacy data in this study. Other Per- Protocol Sets may be defined.
