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The variables in LookInfo define the multiple looks design parameters. They can be used in custom scripts for the Analysis Integration Point and the Treatment Selection Integration Point. To access these parameters in your R code, use the syntax: LookInfo$NameOfTheVariable, replacing NameOfTheVariable with the appropriate parameter name.

The tables below describe each variable and notes any conditions under which it can or cannot be used in a project on East Horizon Explore and East Horizon Design. Availability notes are only specified when they differ from the default availability of the integration points (see the pages linked above for details).

LookInfo is only available for Statistical Design = Group Sequential.

For Study Objective = Two Arm Confirmatory

For Endpoint Type = Continuous, Binary, Time-to-Event, Continuous with Repeated Measures

Variable Type Description Notes for Explore Notes for Design
NumLooks Integer Number of looks.
CurrLookIndex Integer Current index look, starting from 1.
InfoFrac Vector of Numeric Vector of length LookInfo$NumLooks, containing the information fraction for each look.
CumAlpha Vector of Numeric Vector of length LookInfo$NumLooks, containing the cumulative alpha spent (for one-sided tests) for each look. Only available if Test Type = One-sided.
CumAlphaLower Vector of Numeric Vector of length LookInfo$NumLooks, containing the lower cumulative alpha spent (for two-sided tests) for each look. Same as CumAlpha if left-tailed one-sided test. Only makes sense to use for two-sided asymmetric tests. Only available if Tail Type = Left-tailed. Two-sided tests do not exist, so this variable is not useful: use CumAlpha instead. Only available if Test Type = One-sided and Tail Type = Left-tailed, or Test Type = Two-sided asymmetric or symmetric.
CumAlphaUpper Vector of Numeric Vector of length LookInfo$NumLooks, containing the upper cumulative alpha spent (for two-sided tests) for each look. Same as CumAlpha if right-tailed one-sided test. Only makes sense to use for two-sided asymmetric tests. Only available if Tail Type = Right-tailed. Two-sided tests do not exist, so this variable is not useful: use CumAlpha instead. Only available if Test Type = One-sided and Tail Type = Right-tailed, or Test Type = Two-sided asymmetric or symmetric.
CumCompleters Vector of Integer Vector of length LookInfo$NumLooks, containing the cumulative number of completers for each look. Not available for Endpoint Type = Time-to-Event and for Vaccine Efficacy (Endpoint Type = Binary with Lower Value and Test = 1 - Ratio of Proportions or 1 - Ratio of Poisson Rates). Not available for Time-to-Event tests.
CumEvents Integer Cumulative events. Only available for Endpoint Type = Time-to-Event and for Vaccine Efficacy (Endpoint Type = Binary with Lower Value and Test = 1 - Ratio of Proportions or 1 - Ratio of Poisson Rates). Only available for Time-to-Event tests.
LookTime Numeric Look time on calendar scale. Only available for Time-to-Event tests if Look Fix Option = Time-based.
RejType Integer Rejection type. Possible values:
0: One-sided efficacy upper.
1: One-sided futility upper.
2: One-sided efficacy lower.
3: One-sided futility lower.
4: One-sided efficacy upper, futility lower.
5: One-sided efficacy lower, futility upper.
Possible values:
0: One-sided efficacy upper.
1: One-sided futility upper.
2: One-sided efficacy lower.
3: One-sided futility lower.
4: One-sided efficacy upper, futility lower.
5: One-sided efficacy lower, futility upper.
6: Two-sided efficacy only.
7: Two-sided futility only.
8: Two-sided efficacy, futility.
9: Equivalence.
EffBdryScale Integer Efficacy boundary scale. Possible values:
0: Z scale.
Possible values:
0: Z scale.
1: p-value scale.
EffBdry Vector of Numeric Vector of length LookInfo$NumLooks, containing the efficacy boundary values (for one-sided tests) for each look. Set to NA for Endpoint Type = Continuous with Repeated Measures. Only available if Test Type = One-sided.
EffBdryLower Vector of Numeric Vector of length LookInfo$NumLooks, containing the lower efficacy boundary values (for two-sided tests) for each look. Only available if Tail Type = Left-tailed. Two-sided tests do not exist, so this variable is not useful: use EffBdry instead. Only available if Test Type = One-sided and Tail Type = Left-tailed, or Test Type = Two-sided asymmetric or symmetric.
EffBdryUpper Vector of Numeric Vector of length LookInfo$NumLooks, containing the upper efficacy boundary values (for two-sided tests) for each look. Only available if Tail Type = Right-tailed. Two-sided tests do not exist, so this variable is not useful: use EffBdry instead. Only available if Test Type = One-sided and Tail Type = Right-tailed, or Test Type = Two-sided asymmetric or symmetric.
FutBdryScale Integer Futility boundary scale. Possible values:
0: Z scale.
2: Delta scale.
Possible values:
0: Z scale.
1: p-value scale.
2: Delta scale.
3: Conditional power scale.
CPDeltaOption Delta option for conditional power computation:
- 0: Design Delta.
- 1: Estimated Delta.
Not available. Only available if Futility Boundary Scale = Conditional Power.
FutBdry Vector of Numeric Vector of length LookInfo$NumLooks, containing the futility boundary values (for one-sided tests) for each look. Only available if Test Type = One-sided.
FutBdryLower Vector of Numeric Vector of length LookInfo$NumLooks, containing the lower futility boundary values (for two-sided tests) for each look. Only available if Tail Type = Left-tailed. Two-sided tests do not exist, so this variable is not useful: use EffBdry instead. Only available if Test Type = One-sided and Tail Type = Left-tailed, or Test Type = Two-sided asymmetric or symmetric.
FutBdryUpper Vector of Numeric Vector of length LookInfo$NumLooks, containing the upper futility boundary values (for two-sided tests) for each look. Only available if Tail Type = Right-tailed. Two-sided tests do not exist, so this variable is not useful: use EffBdry instead. Only available if Test Type = One-sided and Tail Type = Right-tailed, or Test Type = Two-sided asymmetric or symmetric.
BindingType Integer Binding type:
- 0: Non-binding.
- 1: Binding.
InterimVisit Integer Index of the visit which is driving the interims (starts at 1). Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
FutContrast Integer The contrast based on which futility boundaries are being computed:
0: Primary contrast.
1: Secondary contrast.
Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
IncludePipeline Integer Indicates whether to include pipeline subjects in the interim:
0: Do not include.
1: Include.
Only available for Endpoint Type = Continuous with Repeated Measures. Not available.

For Endpoint Type = Dual (TTE-TTE or TTE-Binary)

Named List of length equal to the number of endpoints, indicating the trial type for each endpoint. For example, TrialType[“Endpoint 1”] is the type for Endpoint 1.

Variable Type Description Notes for Explore
NumEndpointLooks Named List of Integer Named List of length equal to the number of endpoints, indicating the number of looks for each endpoint. For example, NumEndpointLooks[“Endpoint 1”] is the number of looks for Endpoint 1.
NumLooks Integer Number of looks, defined as the maximum across all endpoints.
CurrLookIndex Integer Current index look, starting from 1.
SyncInterim Integer Interim synchronization option:
- 1: Based on endpoint 1.
- 2: Based on endpoint 2.
InputInfoFrac Named List of Vector of Numeric Named List of length equal to the number of endpoints, containing the information fraction vector for each endpoint. For example, InputInfoFrac[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the information fraction for each look for Endpoint 1. For “Endpoint 1”, some initial entries will be NA if SyncInterim = 2. Some later entries will be NA if SyncInterim = 1 and NumEndpointLooks[“Endpoint 2”] > NumEndpointLooks[“Endpoint 1”].
CumCompleters Named List of Vector of Integer Named List of length equal to the number of endpoints, containing the cumulative number of completers vector for each endpoint. For example, CumCompleters[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the cumulative number of completers for each look for Endpoint 1. Not available for Dual Endpoint = TTE-TTE. Set to NA for endpoints with Endpoint Type = Time-to-Event.
CumEvents Named List of Vector of Integer Named List of length equal to the number of endpoints, containing the cumulative events vector for each endpoint. For example, CumEvents[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the cumulative number of events for each look for Endpoint 1. Set to NA for endpoints with Endpoint Type = Binary.
RejType Named List of Integer Named List of length equal to the number of endpoints, containing the rejection type for each endpoint. For example, RejType[“Endpoint 1”] is the rejection type for Endpoint 1. Possible values:
0: One-sided efficacy upper.
1: One-sided futility upper.
2: One-sided efficacy lower.
3: One-sided futility lower.
4: One-sided efficacy upper, futility lower.
5: One-sided efficacy lower, futility upper.
EffBdryScale Named List of Integer Named List of length equal to the number of endpoints, containing the efficacy boundary scale for each endpoint. For example, EffBdryScale[“Endpoint 1”] is the efficacy boundary scale for Endpoint 1. Possible values:
0: Z scale.
EffBdry Named List of Vector of Numeric Named List of length equal to the number of endpoints, containing the efficacy boundary values for each endpoint. For example, EffBdry[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the efficacy boundary values for each look for Endpoint 1. Set to NA if efficacy boundaries are skipped for some looks.
EffBdryLower Vector of Numeric Named List of length equal to the number of endpoints, containing the lower efficacy boundary values for each endpoint. For example, EffBdryLower[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the lower efficacy boundary values for each look for Endpoint 1. Only available if Tail Type = Left-tailed. Two-sided tests do not exist, so this variable is not useful: use EffBdry instead. Set to NA if efficacy boundaries are skipped for some looks.
EffBdryUpper Vector of Numeric Named List of length equal to the number of endpoints, containing the upper efficacy boundary values for each endpoint. For example, EffBdryUpper[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the upper efficacy boundary values for each look for Endpoint 1. Only available if Tail Type = Right-tailed. Two-sided tests do not exist, so this variable is not useful: use EffBdry instead. Set to NA if efficacy boundaries are skipped for some looks.
FutBdryScale Named List of Integer Named List of length equal to the number of endpoints, containing the futility boundary scale for each endpoint. For example, FutBdryScale[“Endpoint 1”] is the futility boundary scale for Endpoint 1. Possible values:
0: Z scale.
2: Delta scale
- 6: Hazard ratio scale.
FutBdry Named List of Vector of Numeric Named List of length equal to the number of endpoints, containing the futility boundary values for each endpoint. For example, FutBdry[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the futility boundary values for each look for Endpoint 1. Set to NA if futility boundaries are skipped for some looks.
FutBdryLower Vector of Numeric Named List of length equal to the number of endpoints, containing the lower futility boundary values for each endpoint. For example, FutBdryLower[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the lower futility boundary values for each look for Endpoint 1. Only available if Tail Type = Left-tailed. Two-sided tests do not exist, so this variable is not useful: use FutBdry instead. Set to NA if futility boundaries are skipped for some looks.
FutBdryUpper Vector of Numeric Named List of length equal to the number of endpoints, containing the upper futility boundary values for each endpoint. For example, FutBdryUpper[“Endpoint 1”] is a vector of length LookInfo$NumLooks containing the upper futility boundary values for each look for Endpoint 1. Only available if Tail Type = Right-tailed. Two-sided tests do not exist, so this variable is not useful: use FutBdry instead. Set to NA if futility boundaries are skipped for some looks.
BindingType Named List of Integer Named List of length equal to the number of endpoints, containing the binding type for each endpoint. For example, BindingType[“Endpoint 1”] is the binding type for Endpoint 1. Possible values:
- 0: Non-binding.
- 1: Binding.

Notes:

  • Dual endpoints are not available for East Horizon: Design.
  • “Endpoint 1” is used as a sample endpoint name. It will be the actual endpoint name as specified by the user.

For Study Objective = Multiple Arm Confirmatory or Dose Finding

Variable Type Description Notes for Explore Notes for Design
NumLooks Integer Number of looks.
CurrLookIndex Integer Current index look, starting from 1.
InfoFrac Vector of Numeric Vector of length LookInfo$NumLooks, containing the information fraction for each look.
CumAlpha Vector of Numeric Vector of length LookInfo$NumLooks, containing the cumulative alpha spent (for one-sided tests) for each look. Only available if Test Type = One-sided.
CumCompleters Vector of Integer Vector of length LookInfo$NumLooks, containing the cumulative number of completers for each look. Not available for Endpoint Type = Time-to-Event. Not available for Time-to-Event tests.
CumEvents Vector of Integer Vector of length LookInfo$NumLooks,containing the cumulative event for each look. Only available for Endpoint Type = Time-to-Event. Not available for Study Objective = Dose Finding. Only available for Time-to-Event tests.
RejType Integer Rejection type:
0: One-sided efficacy upper.
1: One-sided futility upper.
2: One-sided efficacy lower.
3: One-sided futility lower.
4: One-sided efficacy upper, futility lower.
5: One-sided efficacy lower, futility upper.
EffBdryScale Integer Efficacy boundary scale. Not available for Study Objective = Dose Finding. Possible values:
0: Z scale.
Possible values:
1: Adjusted p-value scale.
EffBdry Vector of Numeric Vector of length LookInfo$NumLooks, containing the efficacy boundary values for each look. Not available for Study Objective = Dose Finding.
FutBdryScale Integer Futility boundary scale. Possible values:
2: Delta scale.
6: Hazard ratio scale.
Possible values:
1: Adjusted p-value scale.
2: Delta scale.
6: Hazard ratio scale.
FutBdry Vector of Numeric Vector of length LookInfo$NumLooks, containing the futility boundary values for each look.
PoCScale Integer Proof of concept (PoC) scale:
- 0: High dose vs. control.
Only available for Study Objective = Dose Finding. Not available.
PoCThreshold Vector of Numeric Vector of length LookInfo$NumLooks, containing the proof of concept (PoC) threshold. Only available for Study Objective = Dose Finding. Not available.