Clinical trial NCT02880241
Conditions: Malaria
Sponsor: Medicines for Malaria Venture
Start date: 2017-10-20; Completion date: 2018-09-24
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose including pharmacokinetic assessments. The study will investigate descending single doses of MMV390048 in response to results obtained in the first cohort/dose in each malaria sub-type. The results of this trial will identify active, well-tolerated doses for investigation in combination with a partner drug within a Phase IIb clinical trial.

Detailed description:
The present Phase IIa study aims to confirm, in patients, the observed activity of MMV390048 against P. falciparum in pre-clinical models and the human IBSM human challenge model, and to determine the activity against P. vivax malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose including pharmacokinetic assessments. The study will investigate descending single doses of MMV390048 in response to results obtained in the first cohort/dose in each malaria sub type.

The results of this trial will identify active, well tolerated doses for investigation in combination with a partner drug within a Phase IIb clinical trial.

Preclinical studies using SCID mice inoculated with P. falciparum-infected red blood cells link doses and exposures to the efficacy of MMV390048.38 The active dose in the SCID model causing maximum effect (ED90) against the parasites is 1 mg/kg/day. The MPC derived from the SCID data was 39 ng/ml.39 A human dose for the treatment of P. falciparum was sought that could maintain blood concentrations above 39 ng/ml (100 nM) for 8 days. Assuming linear pharmacokinetics and based on observed data from the Phase I exploratory formulation study in human volunteers, a dose of approximately 20 mg would be estimated to achieve the pharmacodynamic target drug concentration in humans based on the preclinical efficacy data generated in the SCID mice model. For new antimalarial drugs the translation of a predicted efficacious dose from the SCID mouse to the human challenge model and in turn to the treatment of acute, uncomplicated P. vivax or P. falciparum is unknown. To minimise the risk to patients and to ensure the highest probability of success, the maximum safe dose (as determined in healthy volunteers) that maintains a toxicokinetic safety margin to the repeat dose studies was selected for the first cohort in this study. This dose is expected to exceed the predicted MPC on Day 8 and provide significant target coverage at the site of action.

Arms: arm 1: A single oral dose of up to 120mg MMV390048 arm 2: A single oral dose of up to 120mg MMV390048 arm 3: A single oral dose (to be determined) of MMV390048 arm 4: A single oral dose (to be determined) of MMV390048 arm 5: A single oral dose (to be determined) of MMV390048 arm 6: A single oral dose (to be determined) of MMV390048
Interventions: intervention 1: MMV390048
Intervention descriptions: intervention 1: Tablets of 20mg each

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
V1 Final (10 -Mar-17) 
 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
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Page 1 of 56 
 
 
 
 
 
 
 
 
STATISTICAL ANALYSIS PLAN  
FOR DSMB  / INTERIM ANALYSES  
 
 
 
 
 
AN OPEN LABEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABI
LITY AND 
PHARMACOKINETICS OF A SINGLE DOSE OF MMV 390048 IN ADULT PATI ENTS WITH 
ACUTE, UNCOMPLICATED  PLASMODIUM VIVAX OR FALCIPARUM MALARIA 
MONOINFECTION OVER A  35 DAY PERIOD  
MMV_MMV390048_16_02  
 
 
 
 
 
 
 
 
 
 
 
Author 
Martina Wibberg, CRO Trial Statistician
 
Version  
Version 1 , Final 
Date of version  
10-Mar-2017  
Approved by  customer  
Cristina Donini, Project Director MMV, Hilary Johnstone, Clinical Research 
Physician  
 
 
 




V1 Final (10 -Mar-17) 
 
Statistical Analysis Plan
 
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MMV_MMV390048_16_02  
 
 
 
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Document - History  
Version  
Date  
Responsible  
Change information  
Draft 1 
30-Jan -2017  
M. Wibberg  
 
Draft 2 
15-Feb -2017  
M. Wibberg  
Implementation of comments from first review 
cycle  
Draft 3 
1-Mar-2017  
M. Wibberg  
Implementation of comments from review cycle by DSMB 
members  
Final 
10-Mar-2017  
M. Wibberg  
No further changes from draft 3; track changes accepted and 
document finalized  
 


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Statistical Analysis Plan
 
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MMV_MMV390048_16_02  
 
 
 
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List of a bbreviations
 
 
ACPR  
Adequate Clinical and Parasitological Response
 
AE 
Adverse Event  
ALT 
Alanine Amino Transferase
 
AST 
Aspartate Amino Transferase
 
AUC 
Area Under the Plasma Concentration Time 
Curve  
BMI 
Body Mass Index  
BP 
Blood Pressure  
Cmax  
Maximum plasma concentration
 
DSMB 
Data Safety Monitoring Board  
ECG  
Electrocardiogram  
ETF 
Early Treatment Failure
 
LCF 
Late Clinical Failure  
LPF 
Late Parasitological Failure
 
MedDRA 
Medical Dictionary for Regulatory Activities
 
mITT 
Microbiological Intent -to-Treat  
P. falciparum  
Plasmodium  falciparum  
P. vivax  
Plasmodium  vivax 
PCR  
Polymerase Chain Reaction
 
PK 
Pharmacokinetic  
PT 
Preferred Term  
QTcF  
Corrected QT interval, Fridericia
 
QTcB 
Corrected QT interval, Bazett
 
RBC 
Red Blood Cells (erythrocytes)
 
SAE 
Serious Adverse Event
 
SAS  
Statistical Analysis System
 
SRT  
Safety Review Team
 
t1/2 
Estimated terminal phase half life
 
tmax  
Time to reach maximum plasma concentration
 
ULN 
Upper Limit of Normal  
WBC 
White Blood Cells (leukocytes)
 
WHO 
World Health Organization  
 
 
 


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MMV_MMV390048_16_02  
 
 
 
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Table of Contents  
Document - History ..................................................................................................................................
 3 
Abbreviations  
 ..................................................................................................................................
 4 
1. 
Introductio n  ..................................................................................................................................
 6 
2. 
Decision rules for interim analyses
 ...............................................................................................
 7 
3. 
Definitions and data conventions
 ..................................................................................................
 8 
4. 
Analysis sets  ................................................................................................................................
. 9 
5. 
Patient disposition  .........................................................................................................................
 9 
6. 
Demographic data and baseline characteristics
 .........................................................................
 10 
7. 
Concomitant medication
 ..............................................................................................................
 10 
8. 
Safety analyses
 ...........................................................................................................................
 10 
8.1 
Adverse events  .......................................................................................................................
 10 
8.2 
Dermatotoxicity  .......................................................................................................................
 11 
8.3 
Clinical laboratory data ............................................................................................................
 11 
8.3.1  
Haematotoxicity  ...............................................................................................................
 11 
8.3.2  
Hepatotoxicity  ..................................................................................................................
 11 
8.4 
ECG data  ................................................................................................................................
 11 
8.4.1  
Cardiotoxicity  ...................................................................................................................
 11 
8.5 
Vital signs  ................................................................................................................................
 12 
9. 
Efficacy analyses  .........................................................................................................................
 12 
9.1 
Primary efficacy endpoints  ......................................................................................................
 12 
10. 
Pharmacokinetic (PK) data ..........................................................................................................
 12 
11. 
List of outputs  ..............................................................................................................................
 13 
12. 
Table shells   ................................................................................................................................
 14 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
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MMV_MMV390048_16_02  
 
 
 
 
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1. 
Introduction
 
This analysis plan is
 based on the study protocol
 MMV_MMV390048_16_02 , v1.2 dated 26 Jan  2017 
and the DSMB Charter dated
 26 Jan  2017   
The study is designed to enroll 17 patients into each of the planned cohorts as per the following flow 
chart:  
 
 
 
The DSMB will review safety and efficacy data to decide on the further study proceed, as per DSMB 
Charter.  
Up to two interim analyses per malaria arm, i.e., 4 in total, are planned, after each
 of the first 2  cohort s 
in each arm  completes its Day 14 assessment.
 
The purpose of the first
 interim analyses after Cohorts 1A and 1B, respectively, is to determine if the 
respective malaria arm m
ust  be stopped for futility or if enrolment of a second cohort is indicated. The 
arm will be stopped for futility if no more than 1
0 out of the 17 patients are responders for the primary 
ACPR endpoint. If there are 1
1 to 17 responders out of 17 patients, a second cohort of 17 patients 
may be enrolled. The dose for Cohort 2 will be determined based on the responder rate in Cohort 1 
and corresponding safety
 and  pharmacokinetic data. Second interim analyses will occur after each of 
Cohorts 2A and 2B. The purpose of these analyses is to determine:
 
• 
if a dose should be stopped for futility
 
• 
whether or not enrolment of a third cohort is required and to select the appropriate dose for 
that cohort. If two distinct dose levels have been tested in Cohorts 1 and 2, a dose
-response 
logistic regression model may be fitted to support the termination and dose selection 
decisions.  
The interim analyses will be conducted on data to at least Day 14 of each cohort.
 If PCR correction 
data are not available at the time of the interim analyses, decisions regarding dose and cohort 
progression may be based on the crude adequate clinical and parasitological response (
ACPR , for 
definition see Section 3 below)
 for both P. vivax  and P. falciparum . 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
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2. 
Decision rules for interim analyses
 
As stated in the study protocol, the following rules will be applied to decide upon study progression at 
the time point of the interim analyses:
 
After Cohorts 1A/1B  
• 
After the first cohort, the arm will be terminated for futility if less than 11 out of 17 patients (or less 
than a minimum of 60% of patients
) are ACPR responsive on Day 14.
 
• 
If the arm is not terminated for futility after Cohort 1, Cohort 2 may be enrolled to investigate
 
o 
a lower dose if  at least 14 out of 17 patients from
 Cohort 1 were responders (the 
response 
rate was greater than 80%
, i.e., success criteria were met), or
 
o 
a repeat dose if
 11 to 13 out of 17 patients from
 Cohort 1  were responders (the
 response 
rate was greater than 60% but less than 80%
, i.e., the data w ere  regarded as 
inconclusive).  
After Cohorts 2A/2B  
• 
If Cohort 2 investigated a lower dose than Cohort 1:
 
o 
the same progression criteria described for Cohort 1
 will be applie d to Cohort 2 to 
determine whether a further dose de
-escalation or dose repeat is permitted.
 
o 
the safety review team (
SRT ) may elect to re -escalate to an intermediate dose depending 
on the success criteria at the doses from Cohorts 1 and 2.
 
• 
If Cohort 2 inve stigated the same dose as Cohort 1:
 
o 
the arm will be terminated for futility if less than 25 out of 34 patients from both cohorts (or 
72% or less of cumulative patients from both cohorts) were ACPR on Day 14.
 
o 
if the arm is not terminated for futility after Cohorts 1 and 2, Cohort 3 may be enrolled to 
investigate:  
 
a lower dose if  at least 28 out of 34 patients from both cohorts were responders 
(the cumulative response rate was greater than 80%i.e. success criteria were 
met), or  
 
a repeat dose if 25 to 27 out of 34 patients from both cohorts were responders  
(the cumulative  response rate was greater than 72% but less than 80% i.e. the 
data were regarded as inconclusive).
 
Throughout:  
• 
At any stage, the SRT may elect to repeat a dose rather than de
-escalate even 
though success 
criteria may have been met
. 
The minimum Day 14 ACPR responder count to meet the cohort success criteria will be 14 out of 17 
patients. Assuming a binomial distribution, the point estimate of the response rate with 14 out of 17 
responders will be 82.4% with the lower margin of the 90% confidence interval (Clopper
-Pearson 
method) greater than 60% (60.4% to 95.0%). A responder count of 11 to 13 out of 17 patients will be 
regarded as inconclusive and the dose may be repeated in a subsequent cohor
t. The maximum Day 
14 ACPR responder count to declare futility of a dose level after one cohort will be 10 out of 17 
patients (response rate of 58.8% or less) and will be associated with a risk of false conclusion of futility 
of less than 0.1% (alpha <0.001) assuming that the true population response is at least 90%. 
 
If a particular dose is repeated, the minimum combined Day 14 ACPR responder count across the two 
cohorts to meet the success criteria will be 28 out of 34 patients (82.4% response rate; 90% 
confidence interval of 68.1% to 92.0%). A responder count of 25 to 27 out of 34 patients will be 
regarded as inconclusive and the dose may be repeated in a third cohort. The maximum combined 
Day 14 ACPR responder count to declare futility of a dose level after two cohorts will be 24 out of 34 
(response rate of 70.6% or less) and will be associated with a risk of false conclusion of futility of less 
than 0.2% (alpha <0.002) assuming that the true population response is at least 90%.
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
B\SAP \mmv_mmv390048_16_02_dsmb_sa
p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 8 of 56 
 
If a particular dose is repeated across three cohorts, a combined Day 14 ACPR responder count 
across the three cohorts of at least 41 out of 51 patients (80.4% response rate; 90% confidence 
interval of 69.0% to 89.0%) will be required to meet the dose success criteria. An observed 
response 
rate across the 
three cohorts of 78.4% or less (at most 40 out of 51 patients) will be associated with a 
risk of false conclusion of futility of less than 2% (alpha <0.011) assuming that the true population 
response is at least 90%.
 
DSMB safety re ports and interim analyses will be p
rovided  by DATAMAP GmbH, Freiburg, Germany 
using SAS , Version 9.3  or higher  in a Unix environment.  
3. 
Definitions  and data conventions
 
Baseline  
Baseline for analysis purposes will be defined as the last measurement prior to the study drug 
administration, i.e. in general the Day 0, 
pre -dose  assessment.
 Only if the Day 0, pre -dose  is missing 
the screening assessment will be used
 instead . 
Study days and hours since 
dosing  
Study days will be calculated as actual date minus date of study drug intake, i.e.
, the day of the  study 
drug intake will be defined as Day 0.
 
Hours since dos ing will be calculated based on the date and time of the actual measurement in 
relation to the date and time of
 study drug intake.  
In all calculations time of dose will be the time of the initial dose, i.e., irrespective of vomiting.
 
Calculation of Body Mass 
Index (BMI) 
BMI will be calculated as weight (kg) / [height (m)]†
. 
BMI will be rounded to one decimal
 place . 
Calculation of Age  
Age will be calculated from the date of the screening visit and the date of birth and 
will be presented 
as integer value. If the
 date of birth is not available 
the age entered on the CRF will be used.
 
The following SAS code will be used to calculate age where 
’&dob’ is the date of birth and 
’&dat’ is the 
date of visit 1  
floor((intck(’MONTH’,&dob,&dat)-(day(&dat)<day(&dob)))/12) . 
Fe ver 
Fever will be defined as axillary body temperature ≥37.5°C, or oral, rectal or tympanic  body 
temperature ≥38°C. 
Parasitemia  
Parasitemia will be defined 
as a P. vivax  or P. falciparum asexual forms
 count >0 . 
Crude adequate clinical and parasitological 
response  (ACPR)  
Crude  ACPR at Day 14 will be defined as the absence of parasitemia (thick smear) on Day 14, 
irrespective of temperature, in patients who did not previously meet any of the criteria of early 
treatment failure, late clinical failure or late parasitological failure.
 
PCR corrected ACPR
 
The PCR corrected ACPR (
P. falciparum  only) at Day 14 will be defined as the absence of parasitemia
 
(thick smear) on Day 14, irrespective of temperature, in patients who did not previously meet any of 
the criteria of early treatment failure, late clinical failure or late parasitological failure, after adjustment 
for parasitemia due to new infections by 
genotyping using PCR techniques.
 
Early treatment failure (ETF)
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
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p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 9 of 56 
 
ETF is defined as one of the following:
 
• 
Development of any clinical complications (WHO definition of complicated/severe malaria, WHO 
[2012]) on Days 1, 2 or 3 with parasitemia
 
• 
Parasitemia >100,000/µL on Days 0, 1, 2 or 3 with or without fever
 
• 
A ≥25% increase in parasitemia compared to baseline during the period up to 24 hours after 
dosing for P. vivax malaria or up to 12 hours after dosing for 
P. falciparum  malaria, with or without 
fever, and together with  any of the following:  
-  
clinical decline;  
-  
lack of clinical improvement; or 
 
-  
significant decrease in platelet count defined as:
 
- 
a >20% reduction from baseline for patients with a baseline platelet count between 
50,000/mm 3 and 74,999/mm
3 (thrombocytopenia grade 2), or
 
- 
a drop in platelet count to <50,000/mm
3 for patients with a baseline platelet count 
≥75,000/mm3 
• 
Parasitemia >baseline with or without fever, between >24 and 48
 hours after dosing for 
P. vivax 
and between >12 and 36
 hours after dosing for 
P. falciparum ; 
• 
Any parasitemia with fever, or parasitemia >25% of baseline with or without fever, between >48 
and 72  hours after dosing for 
P. vivax and between >36 and 60
 hours after dosing for 
P. 
falciparum ; 
• 
Failure to clear all parasites b
y microscopy associated with axillary temperature ≥37.5°C or 
oral/rectal/tympanic temperature ≥38°C, between >72 and 96 hours for 
P. vivax  and >60 and 96 
hours for P. falciparum . 
Late Clinical Failure (LCF)   
LCF is defined as the presence of any of the following between Day 4 and 14 in a patient who did not 
previously meet any of the criteria of ETF:
 
• 
Danger signs,  
• 
Severe malaria, or  
• 
Parasitemia with fever.  
Late Parasitological Failure (LPF)
  
LPF is defined as the recurrence of parasitemia between Day 4 and 14 without fever in a patient who 
did not previously meet any of the criteria of ETF or LCF.
 
4. 
Analysis s
ets  
All DSMB summaries will be based on all 
enrolled patients of the corresponding cohort who received 
any amount of study medication (safety set).
 
The interim efficacy analyses will be based on the microbiological ITT
 (mITT) analysis set which will 
consist of all patients from the safety set with parasitologically confirmed malaria at baseline and at 
least one post -baseline efficacy assessment (clinical and parasitological data), and for whom no major 
protocol deviations are reported with the potential to affect the evaluation of efficacy.
 Protocol 
deviations leading to exclusion from the mITT analysis will be defined in a separate document.
 
The pharmacokinetic analysis (if data available at the time point of the DSMB/interim analyses) will be 
based on the pharmacokinetic set defined as all patients in the safety set who have at least one 
quantifiable post dose plasma concentration.
 
5. 
P atient disposition
 
A summary table of patient disposition will be provided, presenting per cohort
 
• 
The number of patients 
screened , treated, completed  study, prematurely discontinued
 study.  
• 
The reasons for premature 
discontinuation.  


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
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p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 10  of 56 
 
The number of patients who actually reached the Day 14 visit but have not yet completed / 
discontinued will also be displayed (since DSMB
 / interim analysis  is supposed to occur when all 
patients of a cohort have reached Day 14)
, labelled "Ongoing at Day 14"
. 
A listing of patient disposition data will be provided.
 
6. 
Demographic 
data  and baseline characteristics
 
Standard summary statistics (number of 
available observations, mean, standard deviation, quartiles, 
minimum, median, maximum), or the number
 (%)  of patients will be used, as
 appropriate. The 
following demographics and baseline characteristics will be provided to the DSMB:
 
• 
Patient demographics: sex, race, age, body weight, height, body mass index (BMI), BMI category 
(<25 kg/m†, >=25 kg/m†) . 
• 
Baseline disease characteristics:
 
− Pre-dose  P. vivax  / P. falciparum  asexual forms count (/µL), screening 
P. vivax  / P. falciparum  
gametocytes count (/µL), screening 
P. vivax  / P. falciparum  total count (sum of asexual forms 
and gametocytes)
 determined by both microscopy and qPCR
 with descriptive measures.
 
− Pre -dose  body temperature with descriptive measures and with number (%) of patients with or 
without fever at baseline, as defined in Section 
3, number (%) of patients with history of fever 
within 24 hours.  
− Pre -dose malaria signs
 and symptoms with number 
(%) of patients  
Listings of demographic data and baseline characteristics will be provided.
 
7. 
Concomitant medication
 
Concomitant medication will be listed by patient.
 These will include ATC classification and WHO 
preferred terms.  
8. 
S afety analys
es 
8.1 
Adverse events
 
All adverse events (AEs) will be coded according to the most recent version of the MedDRA dictionary. 
Only treatment emergent 
AEs will be considered , i.e. AEs which  newly started  or increased in intensity
 
after  the study drug administration.
 For all summaries the worst case approach will be taken, i.e. the 
maximum severity by patient will be summarised, as will the closest relationship to study drug
. 
Although every effort will be taken on the data management side to avoid missing data, a
 missing 
category will be added to the tables, if needed.
 
The following AE summaries will be generated
: 
• 
An overview table of the number (%) of patients with any AE, any SAE, any study drug related 
AE/SAE, any AE leading to withdrawal.
 
• 
Number (%) of patients with AEs by MedDRA primary system organ class and preferred term
, 
including the number of events
. The number of events will be defined as all occurrences of an AE, 
i.e., if a patient reported headache twice, it will be counted as two
 events.  
• 
Number  (%) of patients with study drug related 
AEs by MedDRA primary system organ class and 
preferred term, including the number of events
. 
• 
Number (%) of patients with serious 
AEs by MedDRA primary system organ class and preferred 
term , including the number of events
. 
• 
Number  (%)of patients with serious drug
-related AEs by MedDRA primary system organ class and 
preferred term, including the number of events
. 
• 
Listings of all AEs and of all serious AEs.
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
B\SAP \mmv_mmv390048_16_02_dsmb_sa
p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 11  of 56 
 
8.2 
Dermatotoxicity
 
Potential d ermatotoxicity  will be evaluated based on the occurrence of the following AEs:
 
• 
Dermatitis  
• 
Rash  (rash, erythematous rash, macular rash, papular rash, maculo
-papular rash, pruritic rash, 
pustular rash, vesicular rash
) 
 
MedDRA dictionary preferred terms related to "rash"
 and dermatitis as per the attached excel 
spreadsheet will be used
 to identify potential dermatitis events. These will then be flagged in the AE 
listings and will be subject to a medical review.
 
 
8.3 
Clinical laboratory data
 
8.3.1  
Haematotoxicity  
For h aemoglobin, incidence rates of patients having a haemoglobin
 fall of more than 2 g/dl (i.e. , a 
decrease  from baseline < -2 g/dL) will be summarized . 
For absolute neutrophils the number 
(%)of patients with a value below 1,000
 /µL post b aseline will be 
provided.  
Spaghetti plots of haemoglobin values
,  absolute neutrophil counts
 and platelets  until Day 14  (absolute 
values and changes from baseline)
 for all patients  will be provided.  
A summary table with descriptive statistics of platelets over time
 and changes from baseline
 will be 
provided.  
8.3.2  
Hepatotoxicity  
The number (%)of patients with treatment emergent
 liver enzyme elevations as defined below will be 
summarized. Treatment emergent is defined as not meeting the criterion at any pre
-treatment 
measurement. 
 
• 
ALT or AST >  3*ULN with appearance / worsening of fatigue, nausea, vomiting, fever, rash, or 
eosinophilia   
• 
ALT or AST > 5*ULN (raise rapidly in less than 4 weeks or persists for >2 weeks
 
• 
ALT or AST > 8*ULN  
• 
ALT or AST > 3*ULN and Bilirubin > 2*ULN, at the same time point, if conjugated bilirubin >35% 
(Potential Hy’s law cases).
 
The following figures will be provided for liver enzyme data
 of all patients : 
• 
Scatter plot of peak bilirubin versus peak ALT (e
-dish graph ). 
• 
Spaghetti plots of liver function tests
 and of their changes f
rom baseline  over time ( AST, ALT, total 
bilirubin, alkaline phosphatase
). 
Listings  of all clinical laboratory data per patient will be provided
. Potentially notably abnormal values, 
as defined above will be flagged.
 
8.4 
ECG data  
8.4.1  
Cardiotoxicity  
The number  (%) of patients with treatment emergent
 QTc values based on Fridericia’s form
ula as 
defined  in the DMC DSMB Charter and  below will be summarized. Treatment emergent is defined as 
not meeting the criterion at any pre
-treatment measurement. 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
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p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 12  of 56 
 
• 
QTcF prolongation >60 ms
 
• 
QTcF at any time >450 ms
 
The same will be repeated for QTc
 values calculated based on Bazett’s formula, even though not 
mentioned in the DSMB Charter and study protocol.
 
Potential QTc prolongations wi
ll be evaluated by tabulating the changes from pre dose (Day 0) ECG to 
each time point and worst post baseline 
(highest post dosing value) 
according to the categories : 
• 
<= 0 msec (no change, decrease)
 
• 
> 0 - < 30 msec  
• 
30 - 60 msec  
• 
> 60 msec  
 
Further, absolute post dose QTc values
 will be summarized with the following categories
: 
• 
<= 450 msec  
• 
>450  - < 480 msec  
• 
>480  - < 500 msec  
• 
>500 msec  
will be summari sed  per time point and for the highest post dose value
. These tabulations will be 
presented for QTcF and 
QTcB. 
Box-whisker plots of QTcF and QTcB values over time will be provided.
  
A listing of all ECG data per patient will be provided with the above values flagged accordingly.
 
8.5 
Vital signs  
Spaghetti plots of vital signs over time
 and of corresponding changes from baseline
 will be provided.  
9. 
Efficacy analyses
 
9.1 
Primary efficacy endpoints
 
The primary efficacy endpoints are crude ACPR for 
P. vivax  and PCR -corrected ACPR for P. 
falciparum .  
The number (%) of ACPR responders (PCR
-corrected ACPR responders for 
P. falciparum , if 
available) and the associated 95% confidence interval calculated according to the Clopper
 Pearson  
method will be displayed. Further, the number 
(%) of treatment failures and the reason for treatment 
failure (ETF, LPF, LCF) will be tabulated.
 
The interim efficacy analyses will be performed using the mITT set.
 
Listings of all parasite count data determined by microscopy by patient, of PCR 
correction results, if 
available and of parasite count data determined by qPCR, if available will be provided.
 
10. 
Pharmacokinetic
 (PK) data  
If available , PK data will be listed and graphically displayed by patient over time (reported values and 
log-transformed values).
 Further listings of PK concentration data and individual summary values 
(Cmax, tmax, area under the 
plasma concentration 
curve [AUC]) will be provided.  The latter will also be 
summarized by cohort with geometric mean and CV% for C
max and AUC and with median and range 
for tmax. 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
B\SAP \mmv_mmv390048_16_02_dsmb_sa
p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 13  of 56 
 
11. 
List of outputs  
DSMB Table 1  
Patient disposition (Safety set)
 ...............................................................................
 15 
DSMB Table 2  
Demographic characteristics at screening (Safety set)
 ..........................................
 16 
DSMB Table 3  
Baseline disease characteristics (Safety set)
 .........................................................
 19 
DSMB Table 4  
Pre -dose signs and symptoms of malaria (Safety set)
 ...........................................
 22 
DSMB Table 5.1  
Overview of adverse events (Safety set)
 ................................................................
 23 
DSMB Table 5.2  
Incidence of all adverse events by MedDRA primary system organ class and 
 
 
 
preferred term (Safety set)
 ......................................................................................
 24 
DSMB Table 5.3  
Inciden ce of adverse events considered to be study drug related by MedDRA 
 
 
 
primary system organ class and preferred term (Safety set)
 ................................
. 24 
DSMB Table 5.4  
Incidence of all adverse events by MedDRA primary system organ class, preferred 
 
term and maximal severity (Safety set)
 ..................................................................
 25 
DSMB Table 5.5  
Incidence of all adverse events considered to be study drug related by MedDRA 
 
 
 
primary system organ class, preferred term and maximal severity (Safety set)
 .... 25 
DSMB Table 5.6  
Incidence of serious adverse events by MedDRA primary system organ class and 
 
 
 
preferred term (Safety set)
 ......................................................................................
 26 
DSMB Table 5.7  
Incidence of serious adverse events considered to be study drug related by 
 
 
 
MedDRA primary system organ class and preferred term (Safety set)
 ..................  26 
DSMB Table 5.8  
Incidence of adverse events related to dermatotoxicity by MedDRA primary system 
 
 
 
organ class and preferred te
rm ..............................................................................
 26 
DSMB Table 6  
 Number (%) of patients with treatment emergent potential haematotoxicity 
 
(Safety set)  ..............................................................................................................
 27 
DSMB Table 7  
 Number (%) of patients with treatment emergent liver enzyme elevation
 
(Safety set)  ..............................................................................................................
 28 
DSMB Table 8  
 Summary of platelets and changes form baseline in platelets over time
 
 (Safety set)  .............................................................................................................
 29 
DSMB Table 9  
 Number (%) of patients with treatment emergent potential notably abnormal 
 
QTcF or QTcB values (Safety set)
 ..........................................................................
 30 
DSMB Table 10  
Number (%) of patients by QTcF / QTcB category and change from pre dose in 
 
 
 
QTcF / QTcB category (Safety set)
 ........................................................................
 31 
DSMB Table 11  
Number (%) of patients with Day 14 ACPR response (mITT set)
 ..........................  32 
DSMB Table 12  
Plasma pharmacokinetic variable of MMV390048
 .................................................
 33 
DSMB Figure 1  
Scatter plot of peak post dose total bilirubin versus peak ALT until and including 
 
 
 
Day 14 (Safety set)
 ................................................................................................
. 34 
DSMB Figure 2  
Spaghetti plot of haemoglobin and changes from baseline in haemoglobin over 
 
 
 
time (Safety set)  ......................................................................................................
 35 
DSMB Figure 3  
Spaghetti plot of absolute neutrophils and changes from baseline in absolute 
 
 
 
neutrophils over time (Safety set)
 ...........................................................................
 37 
DSMB Figure 4   
Spaghetti plot of platelets and changes from baseline in platelets over time
 
  
(Safety set) ..............................................................................................................
 37 
DSMB Figure 5  
Spaghetti plot of ALT and changes from baseline in ALT over time (Safety set)
 ... 37 
DSMB Figure 6  
Spaghetti plot of AST and changes from baseline in AST over time (Safety set)
 .. 37 
DSMB Figure 7   
Spaghetti plot of total bilirubin and changes from baseline in total bilirubin over time
 
  
(Safety set) ..............................................................................................................
 37 
DSMB Figure 8  
Spaghetti plot of alkaline phosphatase and changes from baseline in alkaline 
 
 
 
phosphatase over time (Safety set)
 ........................................................................
 37 
DSMB Figure 9  
Spaghetti plot of systolic blood pressure and changes from baseline in systolic 
 
 
 
blood pressure over time (Safety set)
 .....................................................................
 38 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
 
 
P:\projects \mmv\mmve0017 \document \DSM
B\SAP \mmv_mmv390048_16_02_dsmb_sa
p_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 14  of 56 
 
DSMB Figure 10  
Spaghetti plot of diastolic blood pressure and changes from baseline in diastolic 
 
 
 
blood pressure over time (Safety set)
 .....................................................................
 38 
DSMB Figure 11  
Spaghetti plot of pulse rate and changes from baseline in pulse rate over time 
 
 
 
(Safety set) ..............................................................................................................
 38 
DSMB Figure 12  
Spaghetti plot of body temperature and changes from baseline in body 
 
temperature over time (Safety set)
 .........................................................................
 38 
DSMB Figure 13  
Box-Whisker plot of QTcF values over time (Safety set)
 ........................................
 39 
DSMB Figure 14  
Box-Whisker plot of QTcB values over time (Safety set)
 .......................................
 40 
DSMB Figure 15  
PK concentrations over time by patient (Safety set)
 ..............................................
 40 
DSMB Listing 1  
Study completion (Safety set)
 .................................................................................
 41 
DSMB Listing 2  
Protocol deviations (Safety set)
 ..............................................................................
 42 
DSMB Listing 3  
Demographic data (Safety set)
 ...............................................................................
 43 
DSMB Listing 4  
Blood film microscopy data (Safety set)
 ................................................................
. 44 
DSMB Listing 5  
qPCR data (Safety set)
 ...........................................................................................
 45 
DSMB Listing 6  
Study drug administration (Safety set)
 ...................................................................
 46 
DSMB Listing 7  
Adverse events  (Safety set) ....................................................................................
 47 
DSMB Listing 8  
Haematology values, by parameter
 (Safety set)  ....................................................
 48 
DSMB Listing 9  
Biochemistry values, by parameter
 (Safety set)  .....................................................
 49 
DSMB Listing 10  
ECG data (Safety set)
 .............................................................................................
 50 
DSMB Listing 11  
ECG abnormalities (Safety set)
 ..............................................................................
 51 
DSMB Listing 12  
Vital signs (Safety set)
 ............................................................................................
 52 
DSMB Listing 13  
Individual pharmacokinetic concentration data (Pharmacokinetic set)
 ..................  53 
DSMB Listing 14  
Pharmacokinetic summary data (Pharmacokinetic set)
 .........................................
 54 
DSMB Listing 15  
Concomitant medication (Safety set)
 ......................................................................
 55 
DSMB Listing 16  
Patient profiles (Safety set)
.....................................................................................
 56 
 
12. 
T able shells
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
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DATAMAP GmbH 
Page 15  of 56 
 
DSMB Table 1  Patient disposition (Safety set) 
              (Page 1 of 1) 
 
 
Cohort XX
 
Cohort YY
 
 
 
 
Patients enrolled
 
xxx (100.0)
 
 
Patients treated
 
xx (xx.x)
 
 
Patients completed
 
xx (xx.x)
 
 
Patient continuing
 at Day 14
 
xx (xx.x)
 
 
 
 
 
Withdrawn from study prematurely
 
xx (xx.x)
 
 
   
Reason 1
 
xx (xx.x)
 
 
   
Reason 2
 
xx (xx.x)
 
 
   
Reason 3
 
xx (xx.x)
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
Note:  Percentages are based on the number of 
enrolled
 patients.
 
 
 
 
Programming note: Display all potential reasons for withdrawal from the CRF, even if no patient fulfilled the reason.  
 
RELATED TO ALL TABLES 
Data for all cohorts recruited up to the time point of the DSMB analysis will be displayed (one column per cohort). 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 16  of 56 
 
DSMB Table 2  Demographic characteristics at screening (Safety set) 
              (Page 1 of 3) 
 
Variable/
 
   
Statistic/Category
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
 
 
 
 
 
Gender, n (%)
 
 
 
 
   
Male  
xx (xx.x)
 
 
 
   
Female  
xx (xx.x)
 
 
 
 
 
 
 
Age (years)
 
 
 
 
   
Available observations
 
xx  
 
 
   
Mean 
xx.x  
 
 
   
Standard deviation
 
x.xx  
 
 
   
Minimum  
xx  
 
 
   
Q1 
xx.x  
 
 
   
Median  
xx  
 
 
   
Q3 
xx.x  
 
 
   
Maximum 
xx  
 
 
 
 
 
 
Race, n (%)
 
 
 
 
   
Caucasian
 
xx (xx.x)
 
 
 
   
Black  
xx (xx.x)
 
 
 
   
Asian/Oriental
 
xx (xx.x)
 
 
 
   
Other  
xx (xx.x)
 
 
 
 
 
 
 
Missing values were not included in the calculation of percentages.
 
Body mass index = weight in kg / (height in m)**2
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 17  of 56 
 
DSMB Table 2  Demographic characteristics at screening (Safety set) 
              (Page 2 of 3) 
 
Variable/
 
   
Statistic/Category
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
 
 
 
 
 
Height (cm)
 
 
 
 
   
Available observations
 
xx  
 
 
   
Mean 
xxx.x  
 
 
   
Standard deviation
 
xx.xx  
 
 
   
Minimum  
xxx  
 
 
   
Q1 
xxx  
 
 
   
Median  
xxx.x  
 
 
   
Q3 
xxx  
 
 
   
Maximum 
xxx  
 
 
 
 
 
 
Body weight
 (kg)  
 
 
 
   
Available observations
 
xx  
 
 
   
Mean 
xx.x  
 
 
   
Standard deviation
 
x.xx  
 
 
   
Minimum  
xx.x  
 
 
   
Q1 
xx.x  
 
 
   
Median  
xx.x  
 
 
   
Q3 
xx.x  
 
 
   
Maximum 
xx.x  
 
 
 
 
 
 
Missing values were not included in the calculation of percentages.
 
Body mass 
index = weight in kg / (height in m)**2
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 18  of 56 
 
DSMB Table 2  Demographic characteristics at screening (Safety set) 
              (Page 3 of 3) 
 
Variable/
 
   
Statistic/Category
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
 
 
 
 
 
Body mass index (kg/m**2)
 
 
 
 
   
Available observations
 
xx  
 
 
   
Mean 
xx.xx  
 
 
   
Standard deviation
 
x.xxx  
 
 
   
Minimum  
xx.x  
 
 
   
Q1 
xx.xx  
 
 
   
Median  
xx.xx  
 
 
   
Q3 
xx.xx  
 
 
   
Maximum 
xx.x  
 
 
 
 
 
 
Body mass index
 category
, n (%)
 
 
 
 
   
<= 25 kg/m**2
 
xx (xx.x)
 
 
 
   
>25 kg/m**2
 
xx (xx.x)
 
 
 
   
Missing
 
x ( - )  
 
 
 
 
 
 
Missing values were not included in the calculation of percentages.
 
Body mass index = weight in kg / (height in m)**2
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 19  of 56 
 
DSMB Table 3  Baseline disease characteristics (Safety set) 
              (Page 1 of 3) 
 
Variable/
 
   
Statistic/Category
 
Cohort XX
 
(N=xx)  
 
Cohort YY
 
(N=xx)  
 
 
 
 
Pre - dose asexual parasites (/uL)
 determined by microscopy
 
 
 
 
   
Available observations
 
xx  
 
 
   
Geometric mean *
 
xxxx.x
 
 
 
   
Mean 
xxxx.x
 
 
 
   
Standard deviation
 
xxxx.x
 
 
 
   
Minimum  
xxxx.x
 
 
 
   
Q1 
xxxx.x
 
 
 
   
Median  
xxxx.x
 
 
 
   
Q3 
xxxx.x
 
 
 
   
Maximum 
xxxx.x
 
 
 
 
 
 
 
Pre - dose g
ametocytes
 determined by microscopy, n (%)
 
 
 
 
   
Yes  
xx (xx.x)
 
 
 
   
No 
xx (xx.x)
 
 
 
 
 
 
 
Pre - dose 
total p
arasites (/uL)
 determined by microscopy
 
 
 
 
   
Available 
observations
 
xx  
 
 
   
Geometric mean *
 
xxxx.x
 
 
 
   
Mean 
xxxx.x
 
 
 
   
Standard deviation
 
xxxx.x
 
 
 
   
Minimum  
xxxx.x
 
 
 
   
Q1 
xxxx.x
 
 
 
   
Median  
xxxx.x
 
 
 
   
Q3 
xxxx.x
 
 
 
   
Maximum 
xxxx.x
 
 
 
 
 
 
 
* Geometric mean was only calculated if all counts were >
0.  
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 20  of 56 
 
DSMB Table 3  Baseline disease characteristics (Safety set) 
              (Page 2 of 3) 
 
Variable/
 
   
Statistic/Category
 
Cohort XX
 
(N=xx)  
 
Cohort YY
 
(N=xx)  
 
 
 
 
Pre - dose asexual parasites (/uL)
 determined by qPCR
 
 
 
 
   
Available observations
 
xx  
 
 
   
Geometric mean *
 
xxxx.x
 
 
 
   
Mean 
xxxx.x
 
 
 
   
Standard deviation
 
xxxx.x
 
 
 
   
Minimum  
xxxx.x
 
 
 
   
Q1 
xxxx.x
 
 
 
   
Median  
xxxx.x
 
 
 
   
Q3 
xxxx.x
 
 
 
   
Maximum 
xxxx.x
 
 
 
 
 
 
 
Pre - dose g
ametocytes
 determined by qPCR, n (%)
 
 
 
 
   
Yes  
xx (xx.x)
 
 
 
   
No 
xx (xx.x)
 
 
 
* Geometric mean was only calculated if all counts were >0.
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 21  of 56 
 
DSMB Table 3  Baseline disease characteristics (Safety set) 
              (Page 3 of 3) 
 
Variable/
 
   
Statistic/Category
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
 
 
 
 
 
 
 
Pre - dose b
ody temperature, n (%)
 
 
 
 
 
   
No fever
 
xx (xx.x)
 
 
 
 
   
Fever  
xx (xx.x)
 
 
 
 
 
 
 
 
 
Descriptive statistics (°C)
 
 
 
 
 
   
Available observations
 
xx  
 
 
 
   
Mean 
xx.x  
 
 
 
   
Standard deviation
 
x.xx  
 
 
 
   
Minimum  
xx.x  
 
 
 
   
Q1 
xx.x  
 
 
 
   
Median  
xx.x  
 
 
 
   
Q3 
xx.x  
 
 
 
   
Maximum 
xx.x  
 
 
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 22  of 56 
 
DSMB Table 4  Pre-dose signs and symptoms of malaria (Safety set) 
              (Page 1 of n) 
 
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
Malaria symptoms
 
n   (%)
 
 
 
 
 
Any  
xx (xx.x)
 
 
   
Symptom 1  
xx (xx.x)
 
 
   
Symptom 2  
xx (xx.x)
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 23  of 56 
 
DSMB Table 5.1  Overview of adverse events (Safety set) 
                (Page 1 of 1) 
 
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
Number (%) of patients with
 
n   (%)
 
 
 
 
 
Any adverse event
 
xx (xx.x)
 
 
Any drug
- related 
adverse event
 
xx (xx.x)
 
 
Any serious adverse event
 
xx (xx.x)
 
 
Any serious drug
- related adverse event
 
xx (xx.x)
 
 
Any adverse event leading to death
 
xx (xx.x)
 
 
Any adverse event leading to withdrawal from study
 
xx (xx.x)
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 24  of 56 
 
DSMB Table 5.2  Incidence of all adverse events by MedDRA primary system organ class and preferred term (Safety set) 
                (Page 1 of n) 
 
 
Primary system organ class
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
   
Preferred term
 
n   (%)
   
/# events
 
 
 
 
 
At least one 
adverse event
 
xx (xx.x)
 / xx
 
 
 
 
 
Primary system organ class 1
 
xx (xx.x)
 / xx
 
 
   
Preferred term 1
 
xx (xx.x)
 / xx
 
 
   
Preferred term 2
 
xx (xx.x)
 / xx
 
 
 
 
 
Primary system organ class 2
 
xx (xx.x)
 / xx
 
 
   
Preferred term 1
 
xx (xx.x)
 / xx
 
 
   
Preferred term 2
 
xx (xx.x)
 / xx
 
 
 
 
 
etc.
 
 
 
A patient with more than one adverse events within a primary system organ class is counted only once for that class.
 
 
 
 
DSMB Table 5.3  Incidence of adverse events considered to be study drug related by MedDRA primary system organ class  
                and preferred term (Safety set) 
 
Programming note: Same shell as Table 5.2;  
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 25  of 56 
 
DSMB Table 5.4  Incidence of all adverse events by MedDRA primary system organ class, preferred term and maximal severity 
                (Safety set) 
                (Page 1 of n) 
 
 
Maximal severity 
 
Primary SOC 
 
Preferred term 
 
Cohort XX
 
(N=xx) 
n (%)  
Cohort YY
 
(N=xx) 
n (%)  
 
 
 
 
 
 
 
 
Total
 
At least one AE
 
Total
 
 
xxx (xx.x)
 
 
 
Mild  
 
 
 
xxx (xx.x)
 
 
 
Moderate
 
 
 
 
xxx (xx.x)
 
 
 
Severe
 
 
 
 
xxx (xx.x)
 
 
 
 
 
 
 
 
 
 
Total
 
Primary SOC 
 
Total
 
 
xxx (xx.x)
 
 
 
Mild  
 
 
 
xxx (xx.x)
 
 
 
 
 
 
 
 
 
 
Moderate
 
 
Preferred term 1
 
 
xxx (xx.x)
 
 
 
 
 
 
 
xxx (xx.x)
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
If a patient reported more than one adverse event within the same category, 
the worst severity was summarised.
 
A patient with more than one adverse event within a primary system organ class is counted only once for that class.
 
 
 
DSMB Table 5.5  Incidence of all adverse events considered to be study drug related by MedDRA primary system organ class, preferred  
                term and maximal severity (Safety set) 
 
Programming note: Same shell as Table 5.4
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 26  of 56 
 
 
DSMB Table 5.6  Incidence of serious adverse events by MedDRA primary system organ class and preferred term (Safety set) 
Programming note: Same shell as Table 5.2 
 
DSMB Table 5.7  Incidence of serious adverse events considered to be study drug related by MedDRA primary system organ class  
                and preferred term (Safety set) 
Programming note: Same shell as Table 
5.2 ; Additional footnote: Study drug related = possibly, probably or definitely related to 
study drug. 
 
DSMB Table 5.8  Incidence of adverse events related to dermatotoxicity by MedDRA primary system organ class and preferred term 
Programming note: Same shell as Table 5.2; Present dermatotoxicity related AEs. 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 27  of 56 
 
DSMB Table 6  Number (%) of patients with treatment emergent potential haematotoxicity (Safety set) 
              (Page 1 of 1) 
 
 
 
Time point
 
 
 
Criterion
 
Cohort 
XX 
(N=xx) 
n /m   
(%)  
Cohort YY
 
(N=xx)  
 
 
 
 
At any time post dose
 
Haemoglobin change >
- 2 g/dL
 
xx  / xx
 ( xx.x )  
 
 
Abs. neutrophil count <1,000 /uL
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
At any time post dose
 
Haemoglobin change >
- 2 g/dL
 
xx  / xx
 ( xx.x )  
 
until Day 14 inclusive
 
Abs. neutrophil count <1,000 /uL
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
24 h post dose
 
Haemoglobin change >
- 2 g/dL
 
xx  / xx
 ( xx.x )  
 
 
Abs. neutrophil count <1,000 /uL
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
48 h post dose
 
Haemoglobin change >
- 2 g/dL
 
xx  / xx
 ( xx.x )  
 
 
Abs. neutrophil count <
1,000 /uL
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
Day 7  
Haemoglobin change >
- 2 g/dL
 
xx  / xx
 ( xx.x )  
 
 
Abs. neutrophil count <1,000 /uL
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
Day 10/11
 
Haemoglobin change >
- 2 g/dL
 
xx  / xx
 ( xx.x )  
 
 
Abs. neutrophil count <1,000 /uL
 
xx  / xx
 ( xx.x )  
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
n is the number of patients fulfilling the criterion at the time point of interest.
 
m is the number of patients with a corresponding measurement at the time point of interest. 
Treatment emergent = present after dosing but not present before dosing.
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 28  of 56 
 
DSMB Table 7  Number (%) of patients with treatment emergent liver enzyme elevation (Safety set) 
              (Page 1 of 1) 
 
 
 
Time point
 
 
Cohort XX
 
(N=xx) 
n /m   
(%)  
Cohort YY
 
(N=xx) 
 
 
 
 
At any time post dose
 
ALT or AST > 3*ULN
 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 5
*ULN 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 8
*ULN 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 3*ULN
 and Bilirubin >
 2*ULN 
xx  / xx
 ( xx.x )  
 
 
 
 
 
At any time post dose until
 
ALT or AST > 3*ULN
 
xx  / xx
 ( xx.x )  
 
Day 14 inclusive
 
ALT or AST > 5
*ULN 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 8
*ULN 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 3*ULN
 and Bilirubin >
 2*ULN 
xx  / xx
 ( xx.x )  
 
 
 
 
 
24 h post dose
 
ALT or AST > 3*ULN
 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 5
*ULN 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 8
*ULN 
xx  / xx
 ( xx.x )  
 
 
ALT or AST > 3*ULN
 and Bilirubin >
 2*ULN 
xx  / xx
 ( xx.x )  
 
etc. 
 
 
 
 
 
 
 
 
n is the number of patients fulfilling the criterion at the time point of interest.
 
m is the number of patients with a corresponding measurement at the time point of interest. 
For combined criteria, the criteria have to be fulfilled at the same visit.  
Treatment emergent
 = present after dosing but 
not present before dosing.
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 29  of 56 
 
DSMB Table 8  Summary of platelets and changes form baseline in platelets over time (Safety set) 
              (Page 1 of 1) 
 
 
Time point
 
n 
Mean 
SD 
Minimum  
Q1 
Median  
Q3 
Maximum 
 
 
 
 
 
 
 
 
 
 
Cohort 
XX (N=xx)  
 
 
 
 
 
 
 
 
 
Absolute values
 
Baseline
 
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
12 hours
 
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
24 hours
 
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
48 hours
 
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
Day 7  
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
Day 10  
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
etc.
 
xx  
xxx.x  
xx.xx  
xxx  
xxx.x  
xxx.x  
xxx.x  
xxx  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Changes from baseline
 
12 hours
 
xx  
xx.x  
xx.xx  
xx  
xx.x  
xx.x  
xx.x  
xx  
 
24 hours
 
xx  
xx.x  
xx.xx  
xx  
xx.x  
xx.x  
xx.x  
xx  
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 30  of 56 
 
DSMB Table 9  Number (%) of patients with treatment emergent potential notably abnormal QTcF or QTcB values (Safety set) 
              (Page 1 of 1) 
 
 
 
Time point
 
 
Cohort XX
 
(N=xx) 
n /m   
(%)  
Cohort YY
 
(N=xx) 
 
 
 
 
At any time post dose
 
QTcF > 450 ms
 
xx  / xx
 ( xx.x )  
 
 
QTcF increase from baseline >60 ms
 
xx  / xx
 ( xx.x )  
 
 
QTcB > 450 ms
 
xx  / xx
 ( xx.x )  
 
 
QTcB increase from baseline >60 ms
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
At any time post dose until
 
QTcF > 450 ms
 
xx  / xx
 ( xx.x )  
 
Day 14 inclusive
 
QTcF increase from baseline >60 ms
 
xx  / xx
 ( xx.x )  
 
 
QTcF > 450 ms
 
xx  / xx
 ( xx.x )  
 
 
QTcF increase from baseline >60 ms
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
24 h post dose
 
QTcF > 450 ms
 
xx  / xx
 ( xx.x )  
 
 
QTcF increase from baseline >60 ms
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
n is the number of patients fulfilling the criterion at the time point of 
interest.
 
m is the number of patients with a corresponding measurement at the time point of interest. 
Treatment emergent = present after dosing but not present before dosing.
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 31  of 56 
 
DSMB Table 10  Number (%) of patients by QTcF / QTcB category and change from pre dose in QTcF / QTcB category (Safety set) 
              (Page 1 of 1) 
 
 
Time point
 
 
Criterion
 
Cohort XX
 
n / m 
(%)  
Cohort YY
 
(N=xx)  
 
 
 
 
At any time post dose
 
Absolute values
 
 
 
 
   
<=450 msec
 
xx  / xx
 ( xx.x )  
 
 
   
>450 -  480 msec  
xx  / xx
 ( xx.x )  
 
 
   
>480 -  500 msec
 
xx  / xx
 ( xx.x )  
 
 
   
>=500 msec
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
 
Increase between 
actual
 value and 
pre dose
  
 
 
 
   
<= 0 msec (decrease)
 
xx  / xx
 ( xx.x )  
 
 
   
>0 -  30 msec
 
xx  / xx
 ( xx.x )  
 
 
   
>30   60 msec
 
xx  / xx
 ( xx.x )  
 
 
   
>60 msec
 
xx  / xx
 ( xx.x )  
 
 
 
 
 
 
 
 
 
At any time post dose 
until Day 14 inclusive
 
.  
 
 
 
 
 
 
24 h post dose
 
 
 
 
 
 
 
 
etc.
 
 
 
 
n is the number of patients fulfilling the criterion at the time point of interest.
 
m is the number of patients with a 
corresponding measurement at the time point of interest.
 
 
Programming note: Continue with 
further time points and QTcB
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 32  of 56 
 
DSMB Table 11  Number (%) of patients with Day 14 ACPR response (mITT set) 
                  (Page 1 of 1) 
 
 
 
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
 
 
 
 
Crude ACPR  
Available observations
 
xx  
 
 
Number (%) of patients with ACPR
 
xx (xx.x)
 
 
 
95% Clopper 
Pearson confidence interval
 
(xx.x, xx.x)
 
 
 
 
 
 
 
Number (%) of treatment failures
 
xx (xx.x)
 
 
 
   
Early treatment failure
 
xx (xx.x)
 
 
 
   
Late clinical failure
 
xx (xx.x)
 
 
 
   
Late parasitological failure
 
xx (xx.x)
 
 
 
 
 
 
PCR- corrected ACPR
 
Available observations
 
xx  
 
 
Number (%) of patients with ACPR
 
xx (xx.x)
 
 
 
95% Clopper 
Pearson
 confidence interval
 
(xx.x, xx.x)
 
 
 
 
 
 
 
Number (%) of 
treatment failures
 
xx (xx.x)
 
 
 
   
Early treatment failure
 
xx (xx.x)
 
 
 
   
Late clinical failure
 
xx (xx.x)
 
 
 
   
Late parasitological failure
 
xx (xx.x)
 
 
 
 
 
 
The minimum Day 14 ACPR responder count to meet the cohort success criteria is 14 out of 17 
patients.
 
A responder count of 11 to 13 out of 17 patients is regarded as inconclusive and the dose may be repeated in a 
subsequent cohort.  
The maximum Day 14 ACPR responder count to declare futility of a dose level after one cohort is 10 out of 17 
patien
ts.
 
 
Programming note: PCR-corrected ACPR only for P. falciparum and only if available. Footnotes will be adjusted if the same dose is 
repeated during the study. 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 33  of 56 
 
DSMB Table 12  Plasma pharmacokinetic variable of MMV390048 
               (Page 1 of 1) 
 
 
Variable
 
 
Statistic
 
Cohort XX
 
(N=xx)  
Cohort YY
 
(N=xx)  
 
 
 
 
Cmax 
n 
xx  
 
 
geometric mean
 
xxx.x  
 
 
CV% 
xxx.x  
 
 
 
 
 
tmax  
n 
xx  
 
 
Median  
xx.x  
 
 
Minimum  
xx.x  
 
 
Maximum 
xx.x  
 
 
 
 
 
AUC(last)
 
n 
xx  
 
 
geometric mean
 
xxx.x  
 
 
CV% 
xxx.x  
 
 
 
 
 
AUC(inf)
 
n 
xx  
 
 
geometric mean
 
xxx.x  
 
 
CV% 
xxx.x  
 
 
 
 
 
 
 
 
 
 
 
Programming note: will only be delivered if PK data is available. 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 34  of 56 
 
 
DSMB Figure 1  Scatter plot of peak post dose total bilirubin versus peak ALT until and including Day 14 (Safety set) 
               (Page 1 of 1) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Programming note: The figure will be similar to the above. The same symbol will be used for all patients. 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 35  of 56 
 
DSMB Figure 2  Spaghetti plot of haemoglobin and changes from baseline in haemoglobin over time (Safety set) 
               (Page 1 of 2) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Programming note: Figure will be similar to the above. Unit and y axis 
will 
be changed appropriately. Present changes from baseline 
scatterplot on second page. Days 21, 28 and 35 will only be displayed if data available. 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 36  of 56 
 
DSMB Figure 2  Spaghetti plot of haemoglobin and changes from baseline in haemoglobin over time (Safety set) 
               (Page 2 of 2) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Programming note: Figure will be similar to the above. Unit and y axis 
will 
be changed appropriately. Present changes from baseline 
scatterplot on second page. Days 21, 28 and 35 will only be displayed if data available. 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 37  of 56 
 
DSMB Figure 3 Spaghetti plot of absolute neutrophils and changes from baseline in absolute neutrophils over time (Safety set) 
Programming note: Same layout as Figure 2 for absolute neutrophils 
 
DSMB Figure 4 Spaghetti plot of platelets and changes from baseline in platelets over time (Safety set) 
Programming note: Same layout as Figure 2 for platelets 
 
DSMB Figure 5 Spaghetti plot of ALT and changes from baseline in ALT over time (Safety set) 
Programming note: Same layout as Figure 2 for ALT 
 
DSMB Figure 6 Spaghetti plot of AST and changes from baseline in AST over time (Safety set) 
Programming note: Same layout as Figure 2 for AST 
 
DSMB Figure 7 Spaghetti plot of total bilirubin and changes from baseline in total bilirubin over time (Safety set) 
Programming note: Same layout as Figure 2 for total bilirubin 
 
DSMB Figure 8 Spaghetti plot of alkaline phosphatase and changes from baseline in alkaline phosphatase over time (Safety set) 
Programming note: Same layout as Figure 2 for alkaline phosphatase 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 38  of 56 
 
DSMB Figure 9 Spaghetti plot of systolic blood pressure and changes from baseline in systolic blood pressure over time 
              (Safety set) 
Programming note: Same layout as Figure 
2 for systolic blood pressure. If necessary due to the amount of assessment time points, 
results obtained during the first 3 days will be shown separately. 
 
DSMB Figure 10 Spaghetti plot of diastolic blood pressure and changes from baseline in diastolic blood pressure over time 
              (Safety set) 
Programming note: Same layout as Figure 
2 for diastolic blood pressure. If necessary due to the amount of assessment time points, 
results obtained during the first 3 days will be shown separately. 
 
DSMB Figure 11 Spaghetti plot of pulse rate and changes from baseline in pulse rate over time (Safety set) 
Programming note: Same layout as Figure 
2 for pulse. If necessary due to the amount of assessment time points, results obtained 
during the first 3 days will be shown separately. 
 
DSMB Figure 12 Spaghetti plot of body temperature and changes from baseline in body temperature over time (Safety set) 
Programming note: Same layout as Figure 2 for pulse. If necessary due to the amount of assessment time points, results obtained 
during the first 3 days will be shown separately.
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 39  of 56 
 
 
DSMB Figure 13  Box-Whisker plot of QTcF values over time (Safety set) 
 
 
Programming note: This figure will be similar to the above showing QTcF values from the ECGs. The axes will be adjusted
 and labelled
 
accordingly. 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 40  of 56 
 
 
DSMB Figure 14  Box-Whisker plot of QTcB values over time (Safety set) 
Programming note: Same layout as Figure 10 
 
DSMB Figure 15  PK concentrations over time by patient (Safety set) 
 
Programming note: This figure will display the individual PK concentration measurements by patient over time. The data for each 
patient will be displayed in a separate curve and several plots (4 or 6) will displayed on one page. Both log transformed and
 raw 
values. 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 41  of 56 
 
DSMB Listing 1  Study completion (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
Date/day of
 
 
Pat.
 
Sex/  
 
withdrawal/
 
 
No.  
Race  
Completed
 
completion
 
Primary reason for withdrawal
 
 
 
 
 
 
xxx xx  
xx /F/Bl
 
No 
ddMMMyyyy/x  
xxxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 42  of 56 
 
DSMB Listing 2  Protocol deviations (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
 
 
 
 
Pat.
 
Sex/  
 
 
Deviation 
 
 
No.  
Race  
Protocol deviation
 
Details
 
day/day
 
 
 
 
 
 
 
 
 
xxxx  
xx/F/Black
 
 xxxxxxxxxxxx
 
xxxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 43  of 56 
 
DSMB Listing 3  Demographic data (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
 
 
Body  
 
 
Pat.
 
Sex/  
Year  of  
Date of 
 
Height
 
weight
 
BMI 
 
No.  
Race  
birth
 
enrolment
 
(cm)  
(kg)  
(kg/m**2)
 
Ethnicity
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ Black  
yyyy  
ddMMMyyyy 
xxx  
xx.x  
xx.x  
xxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BMI = Weight (kg)/[Height (m)]**2
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 44  of 56 
 
DSMB Listing 4  Blood film microscopy data (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
Collection date/
 
P. <xxxxxx> x 
Other species
 
Pat.
 
Sex/  
 
day/time
 
/µL  
 
 
 
No.  
Race  
Visit
 
hours since dosing
 
asexual
 
gametocytes
 
xxxxxx  
ovale
 
malariae
 
 
 
 
 
 
 
 
 
 
xxxx  
xx/F/ Black  
D0 
ddMMMyyyy/xx/hh:mm/xx.x
 
xx,xxx
 
0 
No 
No 
No 
 
 
 
ddMMMyyyy/xx/hh:mm/xx.x
 
xx,xxx
 
xx  
No 
No 
No 
 
 
 
ddMMMyyyy/xx/hh:mm/xx.x
 
xx,xxx
 
0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming note: For P. vivax cohorts present P. vivax counts; for P. falciparum cohort present P. falciparum counts in <xxxxxx> 
column and the other specimen under "Other". If available, add PCR result in case of re-appearance of parasites. 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 45  of 56 
 
DSMB Listing 5  qPCR data (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
Collection date/
 
P. <xxxxxx>x
 
Other species
 
Pat.
 
Sex/  
 
day/time
 
/µL  
 
 
 
No.  
Race  
Visit
 
hours since dosing
 
asexual
 
gametocytes
 
xxxxxx  
ovale
 
malariae
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ Black  
D0 
ddMMMyyyy/xx/hh:mm/xx.x
 
xx,xxx
 
0 
No 
No 
No 
 
 
 
ddMMMyyyy/xx/hh:mm/xx.x
 
xx,xxx
 
xx  
No 
No 
No 
 
 
 
ddMMMyyyy/xx/hh:mm/xx.x
 
xx,xxx
 
0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming note: For P. vivax cohorts present P. vivax counts; for P. falciparum cohort present P. falciparum counts in <xxxxxx> 
column and the other specimen under "Other".
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 46  of 56 
 
DSMB Listing 6  Study drug administration (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
 
 
 
 
 
 
 
Pat.
 
Sex/  
Date/time
 
Number of
 
Patient
 
Date/time
 
Dose  
Number of 
 
Date/time
 
Repeat dose
 
No.  
Race  
of dosing
 
tablets
 
vomited
 
of vomiting
 
repeated
 
tablets
 
of repeat dose
 
vomited
 
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ Black  
ddMMMyyyy/hh:mm  
xx  
Yes  
ddMMMyyyy/hh:mm  
Yes  
 
ddMMMyyyy/hh:mm  
Yes  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 47  of 56 
 
DSMB Listing 7  Adverse events (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
Adverse event
 
 
 
 
Relationship with
 
 
 
Pat.
 
Sex/  
 
INVESTIGATOR TERM/  
Start date/
 
Stop day/
 
Sever -  
Study  
 
 
Action
 
 
No.  
Race  
SAE 
  Preferred term/SOC
 
day  
day  
ity  
drug  
(1)  
(2)  
taken
 
Outcome  
 
 
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/Bl
 
No 
XXXXXXXXXXXX/
 
ddMMMyyyy/ 
ddMMMyyyy/ 
mild  
possible
 
none  
none  
none  
resolved
 
 
 
 
 * xxxxxxxxxxxxx/xxxx
 
xx  
xx  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 0 is defined as the date of 
study drug 
administration.
 
Action taken: 1 = 
Patient withdrawn from study
, 2 = Concomitant medication,
 3 = Hospitalization required or prolonged
 
              
4 = 
Administration of non
- drug therapy
, 5 = Other actions taken, please specify
 
(1) Definitive anti malaria therapy, (2) malaria
 
* Potential dermatotoxicity event
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 48  of 56 
 
DSMB Listing 8  Haematology values, by parameter (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
 
Age/  
 
 
 
 
 
 
 
 
Pat.
 
Sex/  
 
 
 
 
Sampling date/
day/  
Value/
 
 
Clinically
 
No.  
Race  
Parameter
 
Unit  
Normal range
 
Visit
 
time/hours since 
dose  
(L/H)  
 
significant
 
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/Black
 
Haemoglobin
 
g/dL  
xx.x 
-  xx.x  
Day 0  
ddMMMyyyy/ 0 /hh:mm /xxx.x
 
xx.x  / 
L 
 
No 
 
 
 
 
 
24 hours
 
ddMMMyyyy/ 3 /hh:mm /xxx.x
 
xx.x  / 
H 
 
Yes  
 
 
 
 
 
48 hours
 
ddMMMyyyy/ 7 /hh:mm /xxx.x
 
xx.x  / 
L 
 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Day 0 is defined as the date of 
study drug
 administration.
 
L denotes a value below the normal range, H a value above the normal range.
 
 
 
 
Programming note: Haematology variables 
haemoglobin, haematocrit, 
erythrocytes (
RBC), platelets, reticulocytes, white blood cells 
(WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils will be presented. Decimal places will be adapted as appropriate. 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 49  of 56 
 
DSMB Listing 9  Biochemistry values, by parameter (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
 
Age/  
 
 
 
 
 
 
 
 
Pat.
 
Sex/  
 
 
 
 
Sampling date/
day/  
Value/
 
 
Clinically
 
No.  
Race  
Parameter
 
Unit  
Normal range
 
Visit
 
time/hours since dose
 
(L/H)  
 
significant
 
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/Black
 
AST 
U/L  
xx.x 
-  xx.x  
Day 0  
ddMMMyyyy/ 0 /hh:mm/xxx.x
 
xx.x  / 
L 
 
No 
 
 
 
 
 
24 hours
 
ddMMMyyyy/ 3 /hh:mm/xxx.x
 
xx.x  / 
H 
 
Yes  
 
 
 
 
 
48 hours
 
ddMMMyyyy/ 7 /hh:mm/xxx.x
 
xx.x  / 
L 
 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Day 0 is defined as the date of 
study drug
 administration.
 
L denotes a value below the normal range, H a value above the normal range.
 
 
 
 
Programming note: 
Biochemistry 
variables sodium, potassium, creatinine, glucose, total and conjugated bilirubin (conjugated only if 
total bilirubin is elevated), AST, ALT, alkaline phosphatase, creatinine kinase, and haptoglobin (only if patient had haemogl
obin 
related adverse event of special interest) will be presented. Decimal places will be adapted as appropriate. 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 50  of 56 
 
DSMB Listing 10  ECG data (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
 
 
 
 
 
QTc Fridericia
 
QTc Bazett
 
Pat.
 
Sex/  
 
ECG date/day/time/
 
PR 
QRS 
RR 
QT 
 
Change from
 
 
Change from
 
No.  
Race  
Visit
 
hours 
since dose
 
(ms)  
(ms)  
(ms)  
(ms)  
(ms)  
baseline
 
(ms)  
baseline
 
 
 
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ xxxx  
Day 0  
ddMMMyyyy/xx/hh:mm/xx
 
xx  
xx  
xx  
xx  
xxx  
xxx  
xxx  
xx  
 
 
 
 
xx  
xx  
xx  
xx  
xxx  
xxx  
xxx #  
xx *  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Day 0 is defined as the date of 
study drug
 administration.
 
QTc (Fridericia
 / Bazett
): # >450 ms, * change from baseline >60 ms.
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 51  of 56 
 
DSMB Listing 11  ECG abnormalities (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
 
Age/  
 
 
Clinically
 
 
Pat.
 
Sex/  
 
ECG date/day/time/
 
significant
 
 
No.  
Race  
Visit
 
hours 
since dose
 
abnormalities
 
Abnormality details
 
 
 
 
 
 
 
xxxx  
xx/F/Black
 
Day x  
ddMMMyyyy/xx/hh:mm/xx
 
yes  
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 52  of 56 
 
DSMB Listing 12  Vital signs (Safety set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
Vital signs
 
 
Systolic 
 
Diastolic
 
Body  
Location
 
Pat.
 
Sex/  
 
date/day/time/
 
Pulse
 
BP 
BP 
temperature
 
of temp.
 
No.  
Race  
Visit
 
hours 
since dose
 
(bpm)  
(mmHg)  
(mmHg)  
(degree C)
 
measurement
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ xxxx  
Day 0 , Hour 0
 
ddMMMyyyy/xx/hh:mm/xx
x.x  
xx  
xxx  
xx  
xx.x  
axillary
 
 
 
Day 0, Hour 2
 
ddMMMyyyy/xx/hh:mm/xx
x.x  
xx  
xxx  
xx  
xx.x  
axillary
 
 
 
Day 0, Hour 4
 
ddMMMyyyy/xx/hh:mm/xx
x.x  
xx  
xxx  
xx  
xx.x  
axillary
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Day 0 is defined as the date of 
study drug
 administration.
 
BP = blood pressure.
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 53  of 56 
 
DSMB Listing 13  Individual pharmacokinetic concentration data (Pharmacokinetic set) 
                 (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
Sampling
 
 
 
 
Pat.
 
Sex/  
Scheduled
 
date/day/time/
 
Concentration
 
Concentration
 
 
No.  
Race  
time point
 
hours since dose
 
(unit)
 
(log transformed)
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ xxxx  
Day 0 , Hour 0
 
ddMMMyyyy/xx/hh:mm/xx
x.x  
xx.x  
xx.x  
 
 
 
Day 0, Hour 2
 
ddMMMyyyy/xx/hh:mm/xx
x.x  
xx.x  
xx.x  
 
 
 
Day 0, Hour 4
 
ddMMMyyyy/xx/hh:mm/
xx x.x  
xx.x  
xx.x  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Day 0 is defined as the date of 
study drug
 administration.
 
 
Programming note: Only provided when data are available. 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 54  of 56 
 
DSMB Listing 14  Pharmacokinetic summary data (Pharmacokinetic set) 
                (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
 
 
 
 
 
 
Pat.
 
Sex/  
Cmax 
tmax  
AUC(last)
 
AUC(inf)
 
 
 
No.  
Race  
(unit)
 
(hours)
 
(unit)
 
(unit)
 
 
 
 
 
 
 
 
 
 
 
xxxx  
xx /F/ Black  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming note: Only provided when data are available. 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 55  of 56 
 
DSMB Listing 15  Concomitant medication (Safety set) 
                 (Page 1 of n) 
 
Cohort XX: P. xxxxxxxx, xxx mg 
 
 
Age/  
Treatment
 
Dose / unit /
 
 
 
 
Pat.
 
Sex/  
INVESTIGATOR TERM 
frequency /
 
Date/day
 
Date/day
 
 
No.  
Race  
  Preferred term
/ATC class
 
route
 
started
 
stopped/
 
Reason for use
 
 
 
 
 
 
 
 
xxxx  
xx/F/Bl
 
xxxxxxxxxxxxxxxx
 
xxxxxxxx
 
ddMMMyyyy/xx  
ddMMMyyyy/xx  
xxxxxxxxxxxxxxxxx
 
 
 
  xxxxxxxxxxxxxx
/xxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Day 0 is defined as the date of 
study drug
 administration.
 
 
 
 
 
 
 


V1 Final (10 -Mar-17) 
Statistical Analysis Plan
 
for DSMB/Interim Analysis  
MMV_MMV390048_16_02  
 
 
P:\projects \mmv\mmve0017 \document \DSMB\SAP \mmv_mmv39
0048_16_02_dsmb_sap_final_20170310.docx
 
SOP 401, Template 1, Version 7
 
DATAMAP GmbH 
Page 56  of 56 
 
DSMB Listing 16  Patient profiles (Safety set) 
                 (Page 1 of n) 
 
 
This will be a by patient listing of all data collected relevant to the safety and efficacy.