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The variables in DesignParam define the trial 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: DesignParam$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).

For Study Objective = Two Arm Confirmatory

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

Variable Name Type Description Notes for Explore Notes for Design
Alpha Numeric Type I Error. Only available if Test Type = One-sided or Two-sided symmetric.
LowerAlpha Numeric Lower Type I Error. Same as Alpha 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 Alpha instead. Only available if Test Type = One-sided and Tail Type = Left-tailed, or Test Type = Two-sided asymmetric.
UpperAlpha Numeric Lower Type I Error. Same as Alpha 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 Alpha instead. Only available if Test Type = One-sided and Tail Type = Right-tailed, or Test Type = Two-sided asymmetric.
TrialType Integer Trial Type:
0: Superiority.
1: Non-inferiority.
2: Equivalence.
3: Super-superiority.
Type 2 (equivalence) does not exist.
TestType Integer Test Type:
0: One-sided.
1: Two-sided symmetric.
2: Two-sided asymmetric.
Types 1 and 2 (two-sided) do not exist.
TailType Integer Nature of critical region:
0: Left-tailed.
1: Right-tailed.
Only available if Test Type = One-sided.
AllocInfo Vector of Numeric Vector of length equal to the number of treatment arms (number of arms - 1), containing the ratios of the treatment group sample sizes to control group sample size.
CriticalPoint Numeric Critical value (for one-sided tests). Only available if Statistical Design = Fixed Sample. Only available if Test Type = One-sided and Statistical Design = Fixed Sample.
LowerCriticalPoint Numeric Lower critical value. Same as CriticalPoint if left-tailed one-sided test. Only makes sense to use for two-sided asymmetric tests. Only available if Statistical Design = Fixed Sample and Tail Type = Left-tailed. Two-sided tests do not exist, so this variable is not useful: use CriticalPoint instead. Only available if Statistical Design = Fixed Sample. Only available if Test Type = One-sided and Tail Type = Left-tailed, or Test Type = Two-sided symmetric/asymmetric.
UpperCriticalPoint Numeric Lower critical value. Same as CriticalPoint if right-tailed one-sided test. Only makes sense to use for two-sided asymmetric tests. Only available if Statistical Design = Fixed Sample and Tail Type = Right-tailed. Two-sided tests do not exist, so this variable is not useful: use CriticalPoint instead. Only available if Statistical Design = Fixed Sample. Only available if Test Type = One-sided and Tail Type = Right-tailed, or Test Type = Two-sided symmetric/asymmetric.
SampleSize Integer Sample size of the trial.
MaxCompleters Integer Maximum number of completers. 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.
RespLag Numeric Follow-up duration. Not available for Endpoint Type = Time-to-Event. Not available for Time-to-Event tests.
LookFixOption Integer Look option:
- 0: Event-based.
- 1: Time-based.
Not available. Only available for Time-to-Event tests.
MaxEvents Integer Maximum 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.
MaxStudyDur Integer Maximum study duration. Not available. Only available for Time-to-Event tests with Look Fix Option = 1 (Time-based).
FollowUpType Integer Follow-up type:
0: Until the end of the study.
1: For a fixed period.
Only available for Endpoint Type = Time-to-Event. Only available for Time-to-Event tests.
FollowUpDur Numeric Follow-up duration. Only available for Endpoint Type = Time-to-Event. Only available for Time-to-Event tests.
TestStatType Integer Test statistic type. For Time-to-Event tests:
- 0: Logrank.
- 1: Wilcoxon Gehan.
- 2: Harrington Fleming.
- 3: Stratified Logrank.
- 4: Stratified Wilcoxon Gehan.
- 5: Stratified Harrington Fleming.
For Continuous test:
- 3: Z-test.
- 4: t-test.
For Binary test:
- 5: Wald.
- 6: Score.
Not available. Not available for Test = Difference of Proportions or Odds Ratio of Proportions (Binary).
HFParam1 Numeric First parameter of Harrington Fleming. Not available. Only available for Time-to-Event tests.
HFParam2 Numeric Second parameter of Harrington Fleming. Not available. Only available for Time-to-Event tests.
VarType Integer Variance type. For Continuous test:
- 4: Equal
- 5: Unequal.
For Difference of Proportions (Binary) test:
- 0: Pooled.
- 1: Unpooled.
For Ratio of Proportions (Binary):
- 2: Null
- 3: Empirical.
Not available. Not available for Time-to-Event tests or Test = Odds Ratio of Proportions (Binary).
TrtEffNull Numeric Treatment effect under null on natural scale. Not available for Endpoint Type = Continuous with Repeated Measures. Set to 0 for Trial Type = Superiority. Set to Delta0=log(HR0)Delta_0 = log(HR_0) for Endpoint Type = Time-to-Event. Set to (1ρ0)(1-\rho_0) for Vaccine Efficacy (Endpoint Type = Binary with Lower Value and Test = 1 - Ratio of Proportions or 1 - Ratio of Poisson Rates). Set to 0 for Trial Type = Superiority. Set to Delta0=log(HR0)Delta_0 = log(HR_0) for Time-to-Event tests.
MuC Numeric Design mean for the control arm. Not available.
Sigma Numeric Design standard deviation specified in simulations. Not available. Only available for Test = Difference of Means (Continuous) and Test Stat Type = 3 (Z-test).
PiC Numeric Design proportion for the control arm. Not available. Only available for Binary tests.
NumHzrdPrd Integer Number of Hazard pieces. Not available. Only available for Time-to-Event tests.
PrdAt Numeric Period starting value. Not available. Only available for Time-to-Event tests.
LambdaC Numeric Control Hazard rate. Not available. Only available for Time-to-Event tests.
NumVisit Integer Number of visits. Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
VisitTime Vector of Numeric Vector of length NumVisit, indicating the time for each visit. Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
VisitStatus Vector of Integer Vector of length NumVisit, indicating the visit selection status for each visit:
0: Visit has not been selected for analysis.
1: Visit has been selected for analysis.
Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
PrimContrastCoeff Vector of Numeric Vector of length NumVisit, indicating the primary contrast coefficient for each visit. Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
SecContrastCoeff Vector of Numeric Vector of length NumVisit, indicating the secondary contrast coefficient for each visit. Only available for Endpoint Type = Continuous with Repeated Measures. Set to NULL for Statistical Design = Fixed Sample. Not available.
DropImp Integer Dropout imputation method:
0: None.
1: Last observation carried forward (LOCF).
Only available for Endpoint Type = Continuous with Repeated Measures. Not available.
NumStratFactors Integer Number of stratification factors. Only available for Endpoint Type = Time-to-Event with Stratification turned on. Only available for Time-to-Event tests with Stratification turned on.
StratFactors Named List Named list of length NumStratFactors, indicating stratification factors details. For example, StratFactors[“Factor1”] is an array of level names for Factor 1. Only available for Endpoint Type = Time-to-Event with Stratification turned on. Only available for Time-to-Event tests with Stratification turned on.
TestStratFactors Array of Character Array of factor names included in the analysis. Length is between 1 and NumStratFactors. Only available for Endpoint Type = Time-to-Event with Stratification turned on. Not available.
NumSubPops Integer Number of subpopulations. Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.
SubPops Named List Named list of length equal to the number of subpopulations, indicating factor details. For example, SubPops[“Factor1”] is an array of level names for Factor 1. Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.
SubpopName Array of Character Array of length equal to the number of subpopulations, indicating the subpopulation names. Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.
WindCond Integer Winning condition:
- 1: At least subpopulation 1.
- 2: At least subpopulation 2.
- 3: At least subpopulation 3.
- 4: At least subpopulation 4.
- 5: At least one subpopulation.
- 6: At least two subpopulations.
- 7: At least three subpopulations.
- 8: At least four subpopulations.
- 9: At least full population.
- 10: All populations.
Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.
PlanEndTrial Integer Planned end of trial:
- 1: Subpopulation 1.
- 2: Subpopulation 2.
- 3: Subpopulation 3.
- 4: Subpopulation 4.
- 5: Full population.
Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.
TransitionMatrix Matrix of Numeric Transition matrix between all populations, including full population and subpopulations. Dimension of (NumSubPops + 1) x (NumSubPops + 1). Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.
PropAlpha Vector of Numeric Vector of length (NumSubPops + 1), indicating the proportion of alpha for all populations, including full population and subpopulations. Only available for Endpoint Type = Time-to-Event with Stratification and Subpopulations turned on. Not available.

Notes:

  • “Factor 1” is used as a sample factor name (stratification). It will be the actual factor name as specified by the user.

For Endpoint Type = Dual (TTE-TTE or TTE-Binary) (including for Multiplicity Adjustment)

Variable Name Type Description Notes
EndpointType Vector of Integer Vector of length equal to the number of endpoints, indicating the endpoint types:
– 0: Continuous.
– 1: Binary.
– 2: Time-to-Event.
EndpointName Vector of String Vector of length equal to the number of endpoints, containing the endpoint names.
WinCond Integer Winning condition:
- 1: At least endpoint 1.
- 2: At least endpoint 2.
- 3: At least one endpoint.
- 4: Both endpoints.
TailType Named List of Integer Named List of length equal to the number of endpoints, indicating the nature of critical region for each endpoint. For example, TailType[“Endpoint 1”] is the nature for Endpoint 1. Possible values:
0: Left-tailed.
1: Right-tailed.
FollowUpType Named List of Integer Named List of length equal to the number of endpoints, indicating the follow-up type for each endpoint. For example, FollowUpType[“Endpoint 1”] is the type for Endpoint 1. Possible values:
0: Until the end of the study.
1: For a fixed period.
FollowUpDur Named List of Numeric Named List of length equal to the number of endpoints, indicating the follow-up duration for each endpoint. For example, FollowUpDur[“Endpoint 1”] is the duration for Endpoint 1.
TrialType Named List of Integer 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. Possible values:
0: Superiority.
1: Non-inferiority.
VarType Integer Variance type:
- 0: Pooled.
- 1: Unpooled.
Only available for Dual Endpoint = TTE-Binary.
PlanEndTrial Integer Planned end of trial:
- 1: Full information for both endpoints.
- 2: Full information for endpoint 1.
- 3: Full information for endpoint 2.
AllocInfo Vector of Numeric Vector of length equal to the number of treatment arms (number of arms - 1), containing the ratios of the treatment group sample sizes to control group sample size.
Alpha Numeric Type I Error.
CriticalPoint Named List of Numeric Named List of length equal to the number of endpoints, indicating the critical value for each endpoint. For example, CriticalPoint[“Endpoint 1”] is the value for Endpoint 1. Only available if Statistical Design = Fixed Sample.
LowerCriticalPoint Named List of Numeric Named List of length equal to the number of endpoints, indicating the lower critical value for each endpoint. For example, LowerCriticalPoint[“Endpoint 1”] is the value for Endpoint 1. Only available if Statistical Design = Fixed Sample and Tail Type = Left Tailed.
UpperCriticalPoint Named List of Numeric Named List of length equal to the number of endpoints, indicating the upper critical value for each endpoint. For example, LowerCriticalPoint[“Endpoint 1”] is the value for Endpoint 1. Only available if Statistical Design = Fixed Sample and Tail Type = Right Tailed.
SampleSize Integer Sample size of the trial.
MultAdj Integer Multiplicity adjustment method:
- 0: None.
- 1: Fallback.
- 2: Fixed sequence.
- 3: Weighted Bonferroni.
- 4: Weighted Bonferroni-Holms.
- 5: Weighted Hochberg.
Only available if the multiplicity adjustment method is not custom.
TestOrder Integer Testing order:
- 1: Start with endpoint 1.
- 2: Start with endpoint 2.
Only available if Multiplicity Adjustment = 1 (Fallback) or 2 (Fixed Sequence).
MaxEvents Named List of Integer Named List of length equal to the number of endpoints, indicating the maximum events for each endpoint. For example, MaxEvents[“Endpoint 1”] is the maximum events for Endpoint 1. Set to NA for endpoints with Endpoint Type = Binary.
MaxCompleters Named List of Integer Named List of length equal to the number of endpoints, indicating the maximum number of completers for each endpoint. For example, MaxCompleters[“Endpoint 1”] is the maximum number of completers for Endpoint 1. Not available for Dual Endpoint = TTE-TTE. Set to NA for endpoints with Endpoint Type = Time-to-Event.
TrtEffNull Named List of Numeric Named List of length equal to the number of endpoints, indicating the treatment effect under the null hypothesis for each endpoint. For example, TrtEffNull[“Endpoint 1”] is the treatment effect for Endpoint 1. Specified in natural log scale for endpoints with Endpoint Type = Time-to-Event.
AlphaAlloc Named List of Numeric Named List of length equal to the number of endpoints, indicating the type I error allocation (%) for each endpoint. For example, AlphaAlloc[“Endpoint 1”] is the error allocation for Endpoint 1. Not available for Multiplicity Adjustment = 0 (None) or 2 (Fixed Sequence).
TargetSSFA Named List of Numeric Named List of length equal to the number of endpoints, indicating the target sample size (final analysis) for each endpoint. For example, TargetSSFA[“Endpoint 1”] is the target sample size for Endpoint 1. Not available for Dual Endpoint = TTE-TTE. Set to NA for endpoints with Endpoint Type = Time-to-Event.
TestStat Named List of Numeric Named List of length equal to the number of endpoints, indicating the test statistic output for each endpoint. For example, TestStat[“Endpoint 1”] is the test statistic output for Endpoint 1. Set to NA for endpoints with a pending analysis. For example, if “Endpoint 1” is tested first, then for the analysis of “Endpoint 1” we will have TestStat[“Endpoint 2”] = NA.

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 = Two Arm Confirmatory - Multiple Endpoints

Variable Name Type Description
TotalLooks Integer Total number of planned looks.
EndpointName Vector of String Vector of length equal to the number of endpoints, containing the endpoint names.
EndpointType Vector of Integer Vector of length equal to the number of endpoints, indicating the endpoint types. Order matches EndpointName order. Possible values:
0: Continuous.
1: Binary.
2: Time-to-Event.
TailType Vector of Integer Vector of length equal to the number of endpoints, indicating the nature of critical region for each endpoint. Order matches EndpointName order. Possible values:
0: Left-tailed.
1: Right-tailed.
NumPat Integer Total number of patients.
AllocRatio Numeric Treatment allocation ratio: number of patients in the treatment arm over number of patient in the control arm.
TrialType Vector of Integer Vector of length equal to the number of endpoints, indicating the trial type for each endpoint. Order matches EndpointName order. Possible values:
0: Superiority.
1: Non-inferiority.
Alpha Numeric Type I error rate.
TestStatistics Named List Named List of length equal to the number of endpoints, containing the test statistics specifications. Names are user-specified endpoint names from EndpointName. Order also matches EndpointName order. Each element contains:
- Test: Integer test type. Possible values: 0 = None, 1 = Log-Rank (TTE), 2 = Difference of Means (Continuous), 3 = Difference of Proportions (Binary), 4 = Ratio of Proportions (Binary).
- TestStat: Integer test statistic. Possible values: 0 = None, 1 = Log-Rank (TTE), 3 = Harrington Fleming (TTE), 4 = t-statistic (Continuous), 5 = z-statistic (Binary), 6 = Modestly Weighted Log-Rank (TTE).
- Variance: Integer variance. Only available for Binary or Continuous endpoint. Possible values: 1 = Pooled (Binary), 2 = Unpooled (Binary), 3 = Equal (Continuous), 4 = Unequal (Continuous).
- Parameter: Vector of Numeric. Only available for TTE with Harrington Fleming or MWLR. For Harrington Fleming: c(p,q). For MWLR: c(delay,w_max).
TargetInformation Vector of Integer Vector of length equal to the number of endpoints, containing the target information of each endpoint: number of completers for Continuous or Binary, number of events for TTE. Order matches EndpointName order.
MultiplicityDetails List Multiplicity adjustment details. Contains:
- MCP: Integer, multiple comparison procedure. Possible values: 0 = None, 1 = Fallback, 2 = Fixed Sequence, 3 = Bonferroni/Weighted Bonferroni, 4 = Holms, 5 = Weighted Holms, 6 = User-specified GMCP.
- AlphaAlloc: Vector of Numeric of length equal to the number of endpoints, containing the Alpha allocation percentages for each endpoint. Order matches EndpointName order.
- TestOrder: Vector of Integer of length equal to the number of endpoints, containing thetesting order for each endpoint. Available for Fallback or Fixed Sequence only. Order matches EndpointName order.
- TransMax: Matrix of Numeric of size equal to the number of endpoints ×\times the number of endpoints, containing the transitions for Alpha propagation. Available for GMCP only. Order matches EndpointName order.
EffFlg Matrix of Integer Matrix of size equal to the number of analysis looks (rows) ×\times the number of endpoints (columns), containing the efficacy flag indicating which endpoint is selected for efficacy testing at which analysis. Columns order matches EndpointName order. Possible values:
- 1: Test for efficacy.
- 0: Do not test.
FutFlg Matrix of Integer Matrix of size equal to the number of analysis looks (rows) ×\times the number of endpoints (columns), containing the futility flag indicating which endpoint is selected for futility testing at which analysis. Columns order matches EndpointName order. Possible values:
- 1: Test for futility
- 0: Do not test.
FutThrsld Matrix of Numeric Matrix of size equal to the number of analysis looks (rows) ×\times the number of endpoints (columns), containing the futility thresholds. Columns order matches EndpointName order. 0 when futility check is not performed (FutFlg = 0). Depends on the endpoint:
- For TTE endpoint: thresholds represent HR (declare futility if HR > threshold).
- For Binary or Continuous endpoint: thresholds represent Delta (declare futility if Delta < threshold).
EffSpending Named List Named List of length equal to the number of endpoints, containing the Alpha spending details. Names are user-specified endpoint names from EndpointName. Order also matches EndpointName order. Each element contains:
- EffBdry: Integer efficacy boundary type. Possible values: 0 = None, 1 = Spending Function.
- SpendFunc: Integer spending function type. Only available for EffBdry = 1. Possible values: 1 = Lan-DeMets (LD), 2 = Gamma.
- Parameter: Numeric or ineteger value. Only available for EffBdry = 1. Possible values:
- For LD: 1 = O’Brien-Fleming (OF), 2 = Pocock (PK).
For Gamma: numeric values (e.g., 1, -3).
WinCondCriteria List List containing trial winning condition criteria. Contains:
-whichEPs: Vector of Integer of length equal to the number of endpoints, indicating which endpoints are considered for winning condition. Order matches EndpointName order. Possible values: 0 = Not considered, 1 = Considered.
-NumEPsWin: Integer. Number of endpoints that must be won. Can be 0 if MustWinEPs is used.
- MustWinEPs: Vector of Integer of length equal to the number of endpoints, indicating which endpoints must be won for trial success. Order matches EndpointName order. Possible values: 0 = Not required, 1 = Must win.

For Study Objective = Multiple Arm Confirmatory or Dose Finding

Variable Name Type Description Notes for Explore Notes for Design
Alpha Numeric Type I Error.
TrialType Integer Trial Type:
0: Superiority.
TestType Integer Test Type:
0: One-sided.
TailType Integer Nature of critical region:
0: Left-tailed.
1: Right-tailed.
InitialAllocInfo Vector of Numeric Vector of length equal to the number of treatment arms (number of arms - 1), containing the ratios of the treatment group sample sizes to control group sample size.
CriticalPoint Numeric Critical value. Only available if Statistical Design = Fixed Sample. Not available for Study Objective = Dose Finding. Not available for Combining P-Values (MAMS) tests.
SampleSize Integer Sample size of the trial.
MaxCompleters Integer Maximum number of completers. Not available for Endpoint Type = Time-to-Event. Not available for Time-to-Event tests.
RespLag Numeric Follow-up duration. Not available for Endpoint Type = Time-to-Event. Not available for Time-to-Event tests and for for Combining P-Values (MAMS) tests .
MaxEvents Integer Maximum events. Only available for Endpoint Type = Time-to-Event. Not available for Study Objective = Dose Finding. Only available for Time-to-Event tests.
FollowUpType Integer Follow-up type:
0: Until the end of the study.
1: For a fixed period.
Only available for Endpoint Type = Time-to-Event. Not available for Study Objective = Dose Finding. Only available for Time-to-Event tests.
FollowUpDur Numeric Follow-up duration. Only available for Endpoint Type = Time-to-Event. Not available for Study Objective = Dose Finding. Only available for Time-to-Event tests.
TestStatType Integer Test statistic type:
- 3: Z-test.
- 4: t-test.
Only available for Endpoint Type = Continuous. Only available for Continuous tests.
VarType Integer Variance type. For Continuous test:
- 4: Equal
- 5: Unequal.
For Difference of Proportions (Binary) test:
- 0: Pooled.
1: Unpooled.
Not available for Endpoint Type = Timne-to-Event. Not available for Time-to-Event tests.
Sigma Numeric Design standard deviation specified in simulations. Not available. Only available for Test = MAMS Difference of Means: Combining P-Values (Continuous) and Test Stat Type = 3 (Z-test).
PValCombMethod Integer P-value combination method:
- 0: Inverse normal.
Not available. Only available for Combining P-Values (MAMS) tests.
w1 Numeric Inverse normal weights for stage 1. Not available. Only available for Combining P-Values (MAMS) tests.
w2 Numeric Inverse normal weights for stage 2. Not available. Only available for Combining P-Values (MAMS) tests.
MultAdjMethod Integer Multiple comparison procedure. Possible values:
0: Bonferroni.
3: Dunnett’s Single Step.
4: Weighted Bonferroni.
5: Fixed Sequence.
6: Fallback.
7: Hochberg’s Step Up.
Possible values:-
0: Bonferroni.
1: Sidak.
2: Simes.
3: Dunnett’s Single Step.
4: Weighted Bonferroni.
5: Fixed Sequence.
6: Fallback.
7: Hochberg’s Step Up.
10: Holm’s Step Down.
11: Hommel’s Step Up.
12: Dunnett’s Step Down.
13: Dunnett’s Step Up.
NumTreatments Integer Number of treatment arms (number of arms - 1).
AlphaProp Vector of Numeric Vector of length DesignParam$NumTreatments (number of arms - 1), containing the proportion of Alpha for each treatment arm. Only available for Multiple Comparison Procedure = 4 (Weighted Bonferroni) or 6 (Fallback). Not available for Study Objective = Dose Finding. Only available for Multiple Comparison Procedure = 4 (Weighted Bonferroni) or 6 (Fallback). Not available for Test = MAMS Difference of Means: Combining P-Values (Continuous) or MAMS Difference of Proportions: Combining P-Values (Binary) or MAMS Logrank (Time-to-Event).
TestSeq Vector of Integer Vector of length DesignParam$NumTreatments (number of arms - 1), containing the test sequence for each comparison (each treatment arm). Only available for Multiple Comparison Procedure = 5 (Fixed Sequence) or 6 (Fallback). Not available for Study Objective = Dose Finding. Only available for Multiple Comparison Procedure = 5 (Fixed Sequence) or 6 (Fallback). Not available for Test = MAMS Difference of Means: Combining P-Values (Continuous) or MAMS Difference of Proportions: Combining P-Values (Binary) or MAMS Logrank (Time-to-Event).
IsArmPresent Vector or Integer. Vector of length DesignParam$NumTreatments (number of arms - 1), indicating whether each arm is still in the trial or was dropped in the interim:
- 0: Dropped in the interim.
- 1: Still present.
Fixed to 1 for the first look and for Statistical Design = Fixed Sample. Fixed to 1 for the first look and for Statistical Design = Fixed Sample.
UpdatedAllocInfo Vector of Numeric Vector of length DesignParam$NumTreatments (number of arms - 1), containing the updated ratios of the treatment group sample sizes to control group sample size, which may have been updated during treatment selection.