
Variables of DesignParam
Gabriel Potvin
January 09, 2026
VariablesOfDesignParam.RmdThe 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
for Endpoint Type = Time-to-Event. Set to
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
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
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)
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)
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)
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. |