Clinical trial NCT04615949
Conditions: COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor
Sponsor: Cardiol Therapeutics Inc.
Start date: 2021-04-30; Completion date: 2022-11-30
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.

Detailed description:
Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization.

Screening (Day 0-1): Patients hospitalized for COVID-19 within the past 24 hours will be screened. If patient consent can be obtained, baseline assessments will be carried out: Physical examination (including vital signs), ECG including QTc interval assessment, echocardiogram to measure left-ventricular ejection fraction (LVEF), chest X-ray, local laboratory (including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, pregnancy test (in women with child-bearing potential only), lymphocyte count and LDH. A C-SSRS will also be completed. Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer as well as inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10).

If all eligibility criteria are met, the patient will be randomized to either CardiolRx™ or placebo.

Study treatment will be initiated immediately after all baseline assessments have been completed and the patient is randomized (Day1). Oral administration is as follows:

* Day 1 and Day 2: Initial dose: 2.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
* Day 3 and Day 4: Increased to 5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
* Day 5 to Day 28: Increased to 7.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo For the first 7 days and on Day 10, an ECG will be recorded 4 hours post morning dose with QTc intervals measured. If the QTc interval is \>500 msec or an increase of \> 60 msec from baseline is observed, the study medication must be stopped immediately.

If the next higher dose is not tolerated for other reasons, the dose will be reduced to the previous tolerated dose. The highest tolerated dose will be administered until Day 28.

If the patient is discharged before Day 10, the assessments up to Day 10 will be carried out as home visits. After Day 10, all remaining scheduled assessments will be carried out during out-patient visits (or home visits, if out-patient visits are not feasible).

In addition to prolongation of the QTc intervals, careful observation is required to detect other Adverse Drug Reactions (ADRs) and Drug-Drug Interactions (DDIs). Because CardiolRx™, may inhibit the metabolism of other drugs, new symptoms may represent toxicity from a concomitant medication that had previously been well tolerated.

A nasopharyngeal swab will also be done every day until Day 7 and on Day 14 to test for presence of the SARS-CoV-2 virus.

After Day 7, assessments will be carried out on a weekly basis except for as noted above on Day 10.

Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer, inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10) and additional parameters of interest every two days until Day 7 as well as on day 28.

The assessments on Day 28 include the following: Physical examination (including vital signs), ECG (recorded 4 hours post morning dose for measurement of QTc interval), echocardiogram to measure LVEF, chest X-ray, local laboratory assessments, including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, lymphocyte count and LDH. In addition, a C-SSRS will be completed and the patient will be asked to answer a PICQ.

Further follow-up visits are scheduled for Day 45 and Day 60 post randomization. These include a clinical assessment (including vital signs) as well as the completion of the PICQ (PICQ on Day 60 only). Any changes in concomitant medications and (S)AEs will also be recorded.

Arms: arm 1: CardiolRx arm 2: Placebo
Interventions: intervention 1: Cannabidiol, pharmaceutically produced with < 5 ppm THC intervention 2: Placebo
Intervention descriptions: intervention 1: CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food intervention 2: Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food

Protocol documents:
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COMBINED LIST OF DRUGS THAT PROLONG QT AND/OR CAUSE TORSADES DE POINTES (TDP)
CredibleMeds® has reviewed available evidence for the drugs on the following list and 
place them in one of three designated categories: Known Risk of TdP (KR), Possible Risk 
of TdP (PR) or have a Conditional Risk of TdP (CR). The full description of these 
categories can be found on the CredibleMeds.org website.
Generic Name
Brand Name
Abarelix (PR)
Plenaxis
Abiraterone (CR)
Zytiga and others
Aclarubicin (KR)
Aclacin and others
Alfuzosin (PR)
Uroxatral
Alimemazine 
(Trimeprazine) (PR)
Nedeltran and others
Amantadine (CR)
Symmetrel and others
Amiodarone (KR)
Cordarone and others
Amisulpride (CR)
Barhemsys and others
Amitriptyline (CR)
Elavil (Discontinued 
6/13) and others
Amphotericin B (CR)
Fungilin and others
Amsacrine (Acridinyl 
anisidide) (CR)
Amsidine
Anagrelide (KR)
Agrylin and others
Apalutamide (PR)
Erleada
Apomorphine (PR)
Apokyn and others
Aripiprazole (PR)
Abilify and others
Arsenic trioxide (KR)
Trisenox
Artemether/Lumefantrine 
(PR)
Coartem
Artenimol/piperaquine (PR)
Eurartesim
Asenapine (PR)
Saphris and others
Astemizole (KR)
Hismanal
Atazanavir (CR)
Reyataz and others
Atomoxetine (PR)
Strattera
Generic Name
Brand Name
Azithromycin (KR)
Zithromax and 
others
Bedaquiline (PR)
Sirturo
Bendamustine (PR)
Treanda and others
Bendroflumethiazide 
(Bendrofluazide) 
(CR)
Aprinox and others
Benperidol (PR)
Anquil and others
Bepridil (KR)
Vascor
Betrixaban (PR)
Bevyxxa
Bortezomib (PR)
Velcade and others
Bosutinib (PR)
Bosulif
Buprenorphine (PR)
Butrans and others
Cabozantinib (PR)
Cometriq
Capecitabine (PR)
Xeloda
Carbetocin (PR)
Pabal and others
Ceritinib (PR)
Zykadia
Cesium Chloride 
(KR)
Energy Catalyst
Chloral hydrate (CR)
Aquachloral and 
others
Chloroquine (KR)
Aralen
Chlorpromazine (KR)
Thorazine and 
others
Chlorprothixene (KR)
Truxal
Cilostazol (KR)
Pletal
Cimetidine (CR)
Tagamet
Ciprofloxacin (KR)
Cipro and others
Generic Name
Brand Name
Cisapride (KR)
Propulsid
Citalopram (KR)
Celexa and others
Clarithromycin (KR)
Biaxin and others
Clofazimine (PR)
Lamprene
Clomipramine (CR)
Anafranil
Clotiapine (PR)
Entumine
Clozapine (PR)
Clozaril and others
Cobimetinib (PR)
Cotellic
Cocaine (KR)
Cocaine
Crizotinib (PR)
Xalkori
Cyamemazine 
(Cyamepromazine) (PR)
Tercian
Dabrafenib (PR)
Tafinlar
Dasatinib (PR)
Sprycel
Degarelix (PR)
Firmagon and 
others
Delamanid (PR)
Deltyba
Desipramine (PR)
Pertofrane and 
others
Deutetrabenazine (PR)
Austedo
Dexmedetomidine (PR)
Precedex and 
others
Dextromethorphan/Quinidine 
(PR)
Nuedexta
Diphenhydramine (CR)
Benadryl and 
others
Disopyramide (KR)
Norpace
Dofetilide (KR)
Tikosyn
If list is printed, check website at www.crediblemeds.org   •   Please see Disclaimer below   •   List continued over        
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RDIOL 
THERAPEUTICS 
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Generic Name
Brand Name
Dolasetron (PR)
Anzemet
Domperidone (KR)
Motilium and others
Donepezil (KR)
Aricept
Doxepin (CR)
Sinequan and others
Dronedarone (KR)
Multaq
Droperidol (KR)
Inapsine and others
Efavirenz (PR)
Sustiva
Eliglustat (PR)
Cerdelga
Encorafenib (PR)
Braftovi
Entrectinib (PR)
Rozlytrek
Eperisone (CR)
Myonal and others
Epirubicin (PR)
Ellence and others
Eribulin mesylate (PR)
Halaven
Erythromycin (KR)
E.E.S. and others
Escitalopram (KR)
Cipralex and others
Esomeprazole (CR)
Nexium and others
Ezogabine (Retigabine) 
(PR)
Potiga and others
Famotidine (CR)
Pepcid and others
Felbamate (PR)
Felbatol
Fingolimod (PR)
Gilenya
Flecainide (KR)
Tambocor and others
Fluconazole (KR)
Diflucan and others
Fluorouracil (5-FU) (PR)
Adrucil and others
Fluoxetine (CR)
Prozac and others
Flupentixol (PR)
Depixol and others
Fluvoxamine (CR)
Faverin and others
Furosemide (frusemide) 
(CR)
Lasix and others
Galantamine (CR)
Reminyl and others
Generic Name
Brand Name
Garenoxacin (CR)
Geninax
Gatifloxacin (KR)
Tequin
Gemifloxacin (PR)
Factive
Gilteritinib (PR)
Xospata
Glasdegib (PR)
Daurismo
Granisetron (PR)
Kytril and others
Grepafloxacin (KR)
Raxar
Halofantrine (KR)
Halfan
Haloperidol (KR)
Haldol and others
Hydrochlorothiazide (CR)
Apo-Hydro and others
Hydrocodone - ER (PR)
Hysinglaâ„¢ ER and others
Hydroquinidine 
(Dihydroquinidine) (KR)
Serecor
Hydroxychloroquine (KR)
Plaquenil and others
Hydroxyzine (CR)
Atarax and others
Ibogaine (KR)
Ibutilide (KR)
Corvert
Iloperidone (PR)
Fanapt and others
Imipramine (Melipramine) 
(PR)
Tofranil
Indapamide (CR)
Lozol and others
Inotuzumab ozogamicin (PR)
Besponsa
Isradipine (PR)
Dynacirc
Itraconazole (CR)
Sporanox and others
Ivabradine (CR)
Procoralan and others
Ivosidenib (PR)
Tibsovo
Ketanserin (PR)
Sufrexal
Ketoconazole (CR)
Nizoral and others
Lacidipine (PR)
Lacipil and others
Lansoprazole (CR)
Prevacid and others
Generic Name
Brand Name
Lapatinib (PR)
Tykerb and others
Lefamulin (PR)
Xenleta
Lenvatinib (PR)
Lenvima
Leuprolide (Leuprorelin) (PR)
Lupron and others
Levofloxacin (KR)
Levaquin and others
Levomepromazine 
(Methotrimeprazine) (KR)
Nosinan and others
Levomethadone 
(levamethadone) (PR)
Levomethadyl acetate (KR)
Orlaam
Levosulpiride (KR)
Lesuride and others
Lithium (PR)
Eskalith and others
Lofexidine (PR)
Lucemyra
Loperamide (CR)
Imodium
Lopinavir/Ritonavir (PR)
Kaletra and others
Lumateperone (PR)
Caplyta
Lurasidone (PR)
Latuda
Maprotiline (PR)
Ludiomil
Melperone (PR)
Bunil and others
Memantine (PR)
Namenda XR
Mesoridazine (KR)
Serentil
Methadone (KR)
Dolophine and others
Metoclopramide (CR)
Reglan and others
Metolazone (CR)
Zytanix and others
Metronidazole (CR)
Flagyl
Mianserin (PR)
Tolvon
Midostaurin (PR)
Rydapt
Mifepristone (PR)
Korlym and others
Mirabegron (PR)
Myrbetriq
Mirtazapine (PR)
Remeron
If list is printed, check website at www.crediblemeds.org   •   Please see Disclaimer below   •   List continued over        
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Generic Name
Brand Name
Moexipril/Hydrochlorothiazide 
(PR)
Uniretic and others
Moxifloxacin (KR)
Avelox and others
Necitumumab (PR)
Portrazza
Nelfinavir (CR)
Viracept
Nicardipine (PR)
Cardene
Nifekalant (KR)
Shinbit
Nilotinib (PR)
Tasigna
Norfloxacin (PR)
Noroxin and others
Nortriptyline (PR)
Pamelor and others
Nusinersen (PR)
Spinraza
Ofloxacin (PR)
Floxin
Olanzapine (CR)
Zyprexa and others
Omeprazole (CR)
Losec and others
Ondansetron (KR)
Zofran and others
Osilodrostat (PR)
Isturisa
Osimertinib (PR)
Tagrisso
Oxaliplatin (KR)
Eloxatin
Oxytocin (PR)
Pitocin and others
Paliperidone (PR)
Invega and others
Palonosetron (PR)
Aloxi
Panobinostat (PR)
Farydak
Pantoprazole (CR)
Protonix and others
Papaverine HCl (Intra-coronary) 
(KR)
Paroxetine (CR)
Paxil and others
Pasireotide (PR)
Signifor
Pazopanib (PR)
Votrient
Pentamidine (KR)
Pentam
Perflutren lipid microspheres (PR)
Definity and others
Perphenazine (PR)
Trilafon and others
Pilsicainide (PR)
Sunrythm
Pimavanserin (PR)
Nuplazid
Pimozide (KR)
Orap
Pipamperone (PR)
Dipiperon and others
Generic Name
Brand Name
Piperacillin/Tazobactam 
(CR)
Tazosyn and others
Pitolisant (Tiprolisant) (PR)
Wakix
Posaconazole (CR)
Noxafil and others
Pretomanid (PR)
Primaquine phosphate (PR)
Probucol (KR)
Lorelco
Procainamide (KR)
Pronestyl and others
Promethazine (PR)
Phenergan
Propafenone (CR)
Rythmol SR and others
Propofol (KR)
Diprivan and others
Prothipendyl (PR)
Dominal and others
Quetiapine (CR)
Seroquel
Quinidine (KR)
Quinaglute and others
Quinine sulfate (CR)
Qualaquin and others
Ranolazine (CR)
Ranexa and others
Ribociclib (PR)
Kisqali
Rilpivirine (PR)
Edurant and others
Risperidone (CR)
Risperdal
Romidepsin (PR)
Istodax
Roxithromycin (KR)
Rulide and others
Rucaparib (PR)
Rubraca
Saquinavir (PR)
Invirase(combo)
Selpercatinib (PR)
Retevmo
Sertindole (PR)
Serdolect and others
Sertraline (CR)
Zoloft and others
Sevoflurane (KR)
Ultane and others
Siponimod (PR)
Mayzent
Solifenacin (CR)
Vesicare
Sorafenib (PR)
Nexavar
Sotalol (KR)
Betapace and others
Sparfloxacin (KR)
Zagam
Sulpiride (KR)
Dogmatil and others
Sultopride (KR)
Barnetil and others
Generic Name
Brand Name
Sunitinib (PR)
Sutent
Tacrolimus (PR)
Prograf and others
Tamoxifen (PR)
Nolvadex and others
Tazemetostat (PR)
Tazverik
Telaprevir (CR)
Incivo and others
Telavancin (PR)
Vibativ
Telithromycin (PR)
Ketek
Terfenadine (KR)
Seldane
Terlipressin (KR)
Teripress and others
Terodiline (KR)
Micturin and others
Tetrabenazine (PR)
Nitoman and others
Thioridazine (KR)
Mellaril and others
Tiapride (PR)
Tiapridal and others
Tipiracil/Trifluridine (PR)
Lonsurf
Tizanidine (PR)
Zanaflex and others
Tolterodine (PR)
Detrol and others
Toremifene (PR)
Fareston
Torsemide (Torasemide) 
(CR)
Demadex and others
Tramadol (PR)
Crispin and others
Trazodone (CR)
Desyrel and others
Trimipramine (PR)
Surmontil and others
Tropisetron (PR)
Navoban and others
Valbenazine (PR)
Ingrezza
Vandetanib (KR)
Caprelsa
Vardenafil (PR)
Levitra
Vemurafenib (PR)
Zelboraf
Venlafaxine (PR)
Effexor and others
Voriconazole (CR)
VFend
Vorinostat (PR)
Zolinza
Ziprasidone (CR)
Geodon and others
Zotepine (PR)
Losizopilon and others
Zuclopenthixol 
(Zuclopentixol) (PR)
Cisordinol and others
Note: Medicines on this list are reviewed on an ongoing basis to assure that the available evidence supports their continued placement on this list. Because, the list changes regularly, we 
recommend always checking the website at crediblemeds.org for the most up-to-date information. Most drugs have multiple brand names and it is not practical to list them on this form. The 
CredibleMeds.org website provides a partial list of the more common brands. 
Disclaimer and Waiver: The information presented here is intended solely for the purpose of providing general information about health-related matters. It is not intended for any other 
purpose, including but not limited to medical advice and/or treatment, nor is it intended to substitute for the users’ relationships with their own health care providers. To that extent, by use of 
this list and the information it contains, the user affirms the understanding of the purpose and releases AZCERT, Inc. from any claims arising out of his/her use of this list. The Terms of Use 
Agreement for this list and the CredibleMeds website is available at https://www.crediblemeds.org/terms. The absence of drugs from these lists should not be considered an indication that 
they are free of risk of QT prolongation or torsades de pointes. Few medicines have been tested for this risk in patients, especially those with congenital long QT syndrome. This list and the 
CredibleMeds® website are intended for personal and professional use only and are protected by U.S. Copyright (title 17, U.S. Code). Unauthorized commercial use is prohibited.
     Generated: August 11, 2020.     List last revised: May 12, 2020
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RDIOL 
THERAPEUTICS 

SAP_001.pdf: 
 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 1 
 
 
Statistical Analytical Plan 
 
Study Title: 
Study to evaLuate the EfficAcy and Safety of  
CardiolRx™ in PatieNts with COVID-19 and 
Cardiovascular DisEase or Risk Factors 
A double-blind, placebo-controlled trial (LANCER) 
 
Sponsor: 
 
 
 
 
Trial Statistician: 
 
Cardiol Therapeutics Inc. 
602 - 2265 Upper Middle Road East 
Oakville, ON, L6H 0G5, Canada 
 
 
Stuart J. Pocock, BSc., MSc., PhD 
 
Protocol Prepared by: 
Cardiol Therapeutics Inc. 
 
Document type: 
 
Protocol number: 
 
Protocol version: 
 
Protocol date: 
 
Statistical Analytical Plan 
 
CARDIOL 100-03 
 
Amendment 3 
 
September 23, 2021 
Document version: 
 
1.0 
Document Release date: 
January 19, 2023 
 
 
 
 
STATEMENT OF CONFIDENTIALITY: 
The information in this document contains scientific and commercial information that is 
privileged or confidential and may not be disclosed unless such disclosure is required by 
federal law or regulations.  In any event, persons to whom the information is disclosed must 
be informed that the information is privileged or confidential and may not be disclosed by 
them.  These restrictions on disclosure will apply equally to all future information supplied to 
you, which is indicated as privileged or confidential. 
 
 


PROPRIETARY AND CONFIDENTIAL
LANCER Study SAP version 1.0 19JAN2023
Page 2 
Signature Page for Sponsor
Study to evaluate the Efficacy and Safety of CardiolRx™in Patients with COVID-19 
and Cardiovascular Disease or Risk Factors: 
A double-blind, placebo-controlled trial (LANCER)
Statistical Analytical Plan
Reviewed and Approved by:
___________________________________________
__________________
Andrea B. Parker, MSc., PhD      
Date
Director, Clinical Affairs
___________________________________________
__________________
Andrew Hamer, MD
Date 
Chief Medical Officer
___________________________________________
__________________
Stuart J. Pocock, BSc., MSc., PhD
Date
Trial Statistician
24-Jan-2023 | 12:03:15 PST
25-Jan-2023 | 02:58:12 PST
24-Jan-2023 | 10:05:56 PST
__
__
_______________________________
An
A drea B. Parker, MSc., PhD      
Director Clinical Affairs
_______________________________
An
Andrew Hamer, MD
Chief Medical Officer
__
__
________________________________
St
St
St
St
St
St
St
St
Stuart J. Pocock, BSc., MSc., PhD
Triai l Statistician


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 3 
 
TABLE OF CONTENTS 
 
1 
LIST OF ABBREVIATIONS ...................................................................................... 5 
2 
INTRODUCTION ...................................................................................................... 7 
3 
STUDY DESIGN ...................................................................................................... 8 
3.1 
Randomization Methodology................................................................................... 8 
3.2 
Blinding ................................................................................................................... 8 
4 
STUDY OBJECTIVES AND ENDPOINTS ............................................................... 9 
4.1 
Efficacy ................................................................................................................... 9 
4.1.1 
Primary Efficacy Objective ............................................................................... 9 
4.1.2 
Primary Efficacy Outcome ............................................................................... 9 
4.1.3 
Secondary Efficacy Objectives ........................................................................ 9 
4.1.4 
Secondary Efficacy Parameters ....................................................................... 9 
4.1.5 
Other Efficacy Parameters ............................................................................. 10 
4.2 
Safety .................................................................................................................... 11 
4.2.1 
Safety Objective ............................................................................................. 11 
4.2.2 
Safety Endpoints ............................................................................................ 11 
4.3 
Centralized Assessment of Endpoints .................................................................. 11 
5 
DEFINITION OF ANALYSIS POPULATIONS ........................................................ 12 
5.1 
Intention-to-treat population (ITT) ......................................................................... 12 
5.2 
Safety population (SAF) ........................................................................................ 12 
5.3 
Per- protocol population (PPP) ............................................................................. 12 
5.4 
Protocol Deviations ............................................................................................... 12 
6 
STATISTICAL METHODS ..................................................................................... 13 
6.1 
Sample Size Justification ...................................................................................... 13 
6.2 
General Statistical Methods and Data Handling .................................................... 13 
6.2.1 
Computing Environment ................................................................................ 13 
6.2.2 
Continuous Variables ..................................................................................... 13 
6.2.3 
Categorical Variables ..................................................................................... 13 
6.3 
Interim Analysis ..................................................................................................... 14 
6.4 
Statistical Inference ............................................................................................... 14 
6.4.1 
Multiple Comparisons/Multiplicity ................................................................... 14 
6.4.2 
Subpopulations .............................................................................................. 14 
6.5 
Handling of Unscheduled Visits ............................................................................ 14 
6.6 
Handling of Missing Information ............................................................................ 14 
6.6.1 
Incomplete Calendar Dates ........................................................................... 14 
6.6.2 
Definition of First Study Day (SD1) ................................................................ 15 
6.6.3 
Definition of Baseline ..................................................................................... 15 
6.6.4 
Conversion factors ......................................................................................... 15 
6.6.5 
Missing Data .................................................................................................. 16 
7 
DESCRIPTION OF STUDY POPULATION ........................................................... 17 
7.1 
Analysis Populations ............................................................................................. 17 
7.2 
Patient Disposition ................................................................................................ 17 


 
 
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7.3 
Baseline Characteristics ....................................................................................... 17 
7.3.1 
Medical History .............................................................................................. 17 
7.3.2 
Concomitant medication ................................................................................ 17 
7.3.3 
Physical Examination ..................................................................................... 18 
8 
COMPLIANCE WITH STUDY MEDICATION AND DRUG ACCOUNTABILITY ..... 19 
9 
EVALUATION OF EFFICACY AND SAFETY ........................................................ 20 
9.1 
Primary Analysis for Efficacy ................................................................................. 20 
9.1.1 
Proportions of Subjects with an Event ........................................................... 20 
9.2 
Secondary Efficacy Analyses ................................................................................ 20 
9.3 
Other Efficacy and Safety Analyses ...................................................................... 21 
9.3.1 
Binary Outcomes ........................................................................................... 21 
9.3.2 
Columbia Suicide Severity Rating Scale (C-SSRS) ....................................... 21 
9.3.3 
Patient Impression of Change Questionnaire (PICQ) .................................... 22 
9.3.4 
Laboratory Tests ............................................................................................ 22 
9.3.5 
Vital Signs ...................................................................................................... 22 
9.3.6 
ECG ............................................................................................................... 22 
9.3.7 
Chest X-Ray .................................................................................................. 22 
9.3.8 
Adverse Events .............................................................................................. 23 
10 CHANGES TO PLANNED ANALYSES .................................................................. 24 
11 REFERENCES....................................................................................................... 25 
 
 
 
 
 


 
 
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1 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
ACE 
Angiotensin Converting Enzyme 
ALT 
Alanine aminotransferase 
AMI 
Acute myocardial infarction 
ARB 
Angiotensin Receptor Blocker 
AST 
Aspartate aminotransferase 
ATC 
Anatomic Therapeutic Chemical 
AUC 
Area under the curve 
BNP 
Brain natriuretic peptide 
CEC 
Clinical Endpoint Adjudication committee 
CMR 
Cardiac magnetic resonance imaging 
CRF  
Case Report Form 
C-SSRS 
Columbia-Suicide Severity Rating Scale  
CV 
Cardiovascular  
ECMO 
Extracorporeal Membrane Oxygenation 
eCRF 
Electronic Case Report Form 
ECG 
Electrocardiogram 
ECV 
Extracellular volume 
eGFR 
Estimated Glomerular filtration rate 
HF 
Heart failure 
hs-CRP 
High sensitivity-C-reactive protein 
hs-troponin 
High sensitivity-troponin 
ICU 
Intensive Care Unit 
INR 
International normalized ratio 
ITT 
Intention-to-treat 
LDH 
Lactate dehydrogenase 
LGE 
Late gadolinium enhancement 
LV 
Left ventricular 
LVEDV 
Left ventricular end-diastolic volume 


 
 
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Abbreviation 
Definition 
LVEF 
Left ventricular ejection fraction 
LVESV 
Left ventricular end-systolic volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
NT-proBNP 
N-terminal pro b-type natriuretic peptide 
PICQ 
Patient impression of change questionnaire 
PPP 
Per protocol population 
PT 
Preferred Term 
Q1 / Q3 
First / third quartile 
SAE 
Serious Adverse Event 
SAF 
Safety Population 
SAP 
Statistical Analysis Plan 
SD 
Standard deviation 
SD1 
First study day 
SOC  
System Organ Class 
TEAE 
Treatment-emergent Adverse Event 
TNF 
Tumor necrosis factor 
WHO 
World Health Organization 
 


 
 
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2 INTRODUCTION 
This document describes the Statistical Analysis Plan (SAP) for the CARDIOL 100-03 
Protocol (Study to evaluate the Efficacy and Safety of CardiolRx™ in Patients with COVID-
19 and Cardiovascular Disease or Risk Factors [LANCER]. This is a multi-center, double-
blind, randomized, placebo-controlled, parallel group design, 1:1 randomization study. In 
total 422 patients will be randomized (1:1) to either CardiolRx™ or placebo.  
The design and methods of the CARDIOL 100-03 study are described in detail in the study 
protocol Amendment 3, dated September 23, 2021. The criteria for evaluation of study 
results and the analysis populations are defined in section 10 of the study protocol and an 
outline of the statistical analysis plan may be found in section 11 of the same document. 
The purpose of this document is to describe the analyses that will be performed in 
accordance with the protocol in more detail. 
 
As the study was terminated early an abbreviated set of reporting will be generated as 
described herein. This plan will be approved prior to the breaking of the study blind. 
Changes from the protocol are noted. 


 
 
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3 STUDY DESIGN 
3.1 Randomization Methodology 
Randomization will be accomplished by means of a web-based randomization system and 
will be stratified by center. The program used is Medidata Rave RTSM. The randomization 
schedule is generated by an unblinded statistician per the protocol requirements and 
loaded in the system. 
 
The randomization sequence will be generated by random computerized sequence in 
blocks of 4.   
 
3.2 Blinding 
The treatment assignment is double-blinded and will not be known by the patients, the 
physician and clinical staff involved in the patient care. 
The preparation and/or administration of the products will be done by designated personnel 
that are not involved in any other aspects of the trial. 
The study blind will be broken on completion of the clinical study and after the study database 
has been locked. 
The randomization code must not be broken except in emergency situations where the 
identification of a subject’s study treatment is required by an investigator for further 
treatment of the patient. Randomization information will be held by designated individual(s). 
The date and reason for breaking the blind must be recorded. 


 
 
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4 STUDY OBJECTIVES AND ENDPOINTS 
 
4.1 Efficacy 
4.1.1 Primary Efficacy Objective 
As stated in section 4.1.1 of the study protocol, the primary objective for efficacy of the 
CARDIOL 100-03 study is to evaluate the effect of CardiolRx™ on prevention of 
cardiovascular (CV) and COVID-19 complications in patients hospitalized for COVID-19. 
 
4.1.2 Primary Efficacy Outcome 
The primary composite endpoint in this study is to experience one of the following events 
during the first 28 days post randomization: 
 
- All-cause mortality 
- 
Requirement for intensive care unit (ICU) admission and/or ventilatory support due to 
COVID-19 
- CV complications*:  
- 
heart failure (HF) or  
- 
acute myocardial infarction (AMI) or 
- 
Myocarditis or 
- 
new sustained or symptomatic arrhythmia or 
- 
stroke 
*Outcome definitions can be found in Appendix 17.8 of the study protocol. 
 
4.1.3 Secondary Efficacy Objectives 
Secondary objectives include the improvement in other clinical parameters during 28 days 
post randomization. 
 
4.1.4 Secondary Efficacy Parameters 
Secondary efficacy parameters include:  
 
-Win Ratio of Ordinal Outcome Scale endpoint: 
1) not hospitalized and no limitations of activities 
2) not hospitalized, with limitation of activities, home oxygen requirement, or 
both; 


 
 
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Page 10 
3) hospitalized, not requiring supplemental oxygen and no longer requiring 
ongoing medical care 
4) hospitalized, not requiring supplemental oxygen but requiring ongoing 
medical care 
5) hospitalized, requiring any supplemental oxygen; 
6) hospitalized, requiring noninvasive ventilation or use of high-flow oxygen 
devices; 
7) hospitalized, receiving invasive mechanical ventilation or extracorporeal 
membrane oxygenation (ECMO); 
8) MI or stroke diagnosed since randomization 
9) death. 
- 
Change in high sensitivity-troponin (hs-troponin) from baseline to peak elevation during 
the 28-day treatment period 
- 
Change in Tumor Necrosis Factor (TNF)-alpha from baseline to peak elevation during 
the 28-day treatment period 
 
4.1.5 Other Efficacy Parameters 
Other efficacy parameters include:  
 
- 
Percentage of patients developing any one of the primary endpoint components 
within 60 days post randomization 
- 
CV mortality at 28 days post randomization 
- 
Percentage of patients requiring dialysis within 28 days post randomization 
- 
Win ratio of the Ordinal Outcome Scale endpoint within 60 days of randomization 
- 
Patient Impression of Change Questionnaire (PICQ) at Day 28 and at Day 60 
- 
Development of severe lymphopenia, defined as < 1000 cells/ microliter within 28 
days post randomization 
- 
Change in (elevation of) hs-troponin, NT-proBNP, D-dimer and in inflammatory 
markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10) from baseline to Day 7 
(AUC) 
- 
Change from baseline to peak elevation of NT-proBNP, D-dimer and in inflammatory 
markers (hs-CRP, ferritin, IL-1 beta, IL-6, IL-10) during the 28-day treatment period 
- 
Change from baseline to peak elevation of LDH during the 28-day treatment period 
- 
Difference in cardiac magnetic resonance imaging (CMR) parameters: LVEF, 
LVEDV, LVESV, LAESV, ECV, GLS, LV mass, LGE extent and edema between the 


 
 
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two treatment groups after 4 weeks of study treatment (in a subset of patients at 
selected sites). 
 
4.2 Safety 
4.2.1 Safety Objective 
The primary safety objective is to demonstrate that administration of CardiolRx™ in the 
proposed doses in this patient population is safe. 
4.2.2 Safety Endpoints 
The primary safety endpoint is the number of Serious Adverse Events (SAEs) and Adverse 
events (AEs) which occur during the 60-day study period. 
The secondary safety endpoints include changes in C-SSRS, blood chemistry and 
hematology parameters (including lymphocyte count), ALT, AST, bilirubin, eGFR, creatinine, 
INR and QTc interval from Electrocardiogram (ECG) recordings at 5 hours post morning 
dose during 28 days post randomization. 
 
4.3 Centralized Assessment of Endpoints 
The Clinical Endpoint Adjudication Committee (CEC) will consist of at least three clinicians 
appointed by the Steering Committee. The CEC will classify all SAEs using pre-specified 
definitions described in the Event Classification manual, based on medical records and 
other documents. In addition, all endpoints will be verified by the CEC. 


 
 
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5 DEFINITION OF ANALYSIS POPULATIONS 
The following analysis populations will be defined for this trial.  
 
5.1 Intention-to-treat population (ITT) 
The primary analyses will be performed on the ITT population. All patients who were 
randomized will be included in the ITT analyses. 
5.2 Safety population (SAF) 
The Safety Population (SAF) includes all subjects who received any study drug. 
5.3 Per- protocol population (PPP)  
The protocol defined a per-protocol population.  However, due to the early termination of the 
study the PPP will not be generated. 
5.4 Protocol Deviations 
The sponsor, or designee, will be responsible for producing the final protocol 
deviation/violation file (formatted as an Excel file or SAS dataset). This file will be finalized 
prior to hard database lock. Protocol deviations will be reported in a data listing for all 
subjects in the ITT population. 


 
 
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6 STATISTICAL METHODS 
6.1 Sample Size Justification 
Assuming that 19% of patients qualifying for the study in the placebo group would develop 
one or more primary outcomes, a treatment effect of lowering the event rate by 50% (i.e. 
only 9.5% of patients treated with CardiolRx™ would experience a primary outcome event, 
a two-sided alpha of 0.05 and 80% power, 211 patients per group (422 in total) would be 
required. 
 
The protocol contained information to consider an adjustment to the sample size.  Due to 
the early termination of the study no sample size re-estimation will be performed. 
6.2 General Statistical Methods and Data Handling 
Tabulations will be produced for appropriate demographic, baseline, efficacy, and safety 
parameters.   
 
Due to the early termination of the study no statistical testing will be performed, with the 
exception of the bio- and inflammatory marker data (see Section 9).  All summaries will be 
presented descriptively. 
 
Listings will be sorted by treatment and subject ID unless specified otherwise. 
 
6.2.1 Computing Environment 
All analyses will be performed using SAS statistical software (Version 9.4 or later), unless 
otherwise noted.  Medical history and adverse events will be coded using the Medical 
Dictionary for Regulatory Activities (MedDRA). Medications will be coded using the World 
Health Organization (WHO) Drug dictionary. Versions of dictionaries will be indicated in the 
relevant tables and listings. 
 
6.2.2 Continuous Variables 
For continuous variables, the mean, median, standard deviation (SD), first and third 
quartiles (Q1 and Q3), and minimum and maximum values will be presented. Means, 
medians and percentiles will be displayed to one more decimal place than the data, 
dispersion statistics (e.g., standard deviation) will have two more decimal places, and the 
minimum and maximum will be displayed to the same number of decimal places as reported 
in the raw data. 
 
6.2.3 Categorical Variables 
Categorical variables will be summarized by presenting the frequency and percent. 
Percentages will be based on the number of subjects in the column header unless 
otherwise specified in the footnote. For each variable, all categories will be shown. Zero 


 
 
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frequencies (but not the percent) within a category will be presented. Percentages will be 
displayed with one decimal place    
 
6.3 Interim Analysis 
The protocol contained information to describe a formal interim analysis of the primary 
endpoint.  Due to the early termination of the study no interim analysis will be performed. 
6.4 Statistical Inference 
Due to the early termination of the study no statistical testing will be performed, with the 
exception of the bio- and inflammatory marker data (see Section 9).  All summaries will be 
presented descriptively. 
6.4.1 Multiple Comparisons/Multiplicity 
Due to the early termination of the study no adjustments for multiple comparisons are 
defined.  All summaries will be presented descriptively.  
6.4.2 Subpopulations 
Section 11.5 of the protocol defined planned subgroups for exploration of the primary 
endpoint.  Due to the early termination of the study no subgroups will be explored.   
6.5 Handling of Unscheduled Visits  
Visit data will be presented using nominal times as collected in the eCRF.  Both scheduled 
and unscheduled post-baseline visits will be tabulated. Unscheduled visits will be presented 
as ‘Visit.x.xx’ (e.g. Visit 3.01). 
6.6 Handling of Missing Information 
6.6.1 Incomplete Calendar Dates 
All rules explained below for partial / missing dates will be followed unless contradicted by 
any other data recorded on the electronic Case Report Form (eCRF). 
All dates presented in the individual subject listings will be as recorded on the eCRF (i.e., 
not completed as per the below rules). 
 
Missing / Partial Start / Stop Date of Medical History, Adverse Events (AE)  
Missing and partial start and stop date will be imputed for analysis purposes as follows. 
Partial or missing stop date will be imputed as follows: 
If the stop date is completely missing and the event has resolved, or the subject has 
stopped taking the concomitant medication, the stop date will be imputed as the date of the 
subject’s last clinic visit in the study regardless of whether remote or in-office visit. 
• 
If only the year is known, the stop date will be imputed as “31-Dec” of that year or as 
the date of the subject’s last clinic visit in the study if in the same year. 
• 
If the month and year are known, the stop date will be imputed as the last day of that 
month unless the stop date corresponds to the same month as the subject’s last clinic visit 
in which case the date of subject’s last clinic visit in the study will be used instead. 


 
 
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Missing start date will be imputed as follows: 
• 
If the stop date occurs on or after the start of study drug or the event / concomitant 
medication is ongoing, the start date will be imputed as the date of the first dose of study 
drug.  
• 
If the stop date occurs before the start of study drug, the start date of the event / 
concomitant medication will be imputed as the subject’s screening date or the stop date of 
the event / concomitant medication whichever the earlier. 
Partial start date (year present, but month and day missing) 
• 
If the stop date occurs on or after the start of study drug or the event / concomitant 
medication is ongoing, and the year is the same as the year of first dosing the start date will 
be imputed as “01-Jan” of the same year or the date of the first dose of study drug 
whichever is latest. If the year is different from the year of first dosing “01-Jan” will be used. 
• 
If the stop date occurs before the start of study drug, the start date of the event / 
concomitant medication will be imputed as the “01-Jan” of the same year. 
Partial start date (month and year present, but day missing) 
• 
If the stop date occurs on or after the start of study drug or the event / concomitant 
medication is ongoing, the start date will be imputed as the first day of the same month and 
year unless this partial start date is in same month as the first dose of study drug in which 
case the date of first dose of study drug will be used.  
• 
If the stop date occurs before the start of study drug, the start date will be imputed as 
the first day of the month and year of the partial stop date. 
 
If the start time is missing it will be imputed only in the case where the start date of the 
concomitant medication / event corresponds to the date of the first dose of study drug. The 
time will be imputed as the same time as the first dose of study drug. In all other cases the 
time will not be imputed. 
6.6.2 Definition of First Study Day (SD1) 
First study day (SD1) is defined as the date of first administration of study treatment. 
6.6.3 Definition of Baseline 
Baseline is defined as the last record or measure collected prior to the first dose of study 
medication.  
 
If an assessment is collected on SD1 and either time of assessment or time of first dose is 
missing, then such assessment is considered as prior to the first dose. The exception to this 
rule are medications and AEs, which will be considered as concomitant or treatment-
emergent, respectively.   
6.6.4 Conversion factors 
The following conversion factors will be used to convert days into months or years, or vice 
versa, if needed:  
 
1 week = 7 days, 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 16 
1 month = 30.4375 days, and 
1 year = 365.25 days. 
 
The following conversion factors will be used for height and weight: 
1 cm =  0.39370 in, and 
1 kg =  2.20462 lb. 
 
6.6.5 Missing Data 
All attempts will be made to minimize missing follow-up data. Data that are collected only at 
baseline will not be imputed.  
 
Due to the early termination of the study no imputations for missing data will be applied with 
the exception of missing dates as described above.  All summaries will be presented 
descriptively on available data.  


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 17 
7 DESCRIPTION OF STUDY POPULATION 
7.1 Analysis Populations 
The number of subjects meeting criteria for each analysis population will be tabulated.  
 
7.2 Patient Disposition 
The contribution of each centre to each of the two treatment arms and will be tabulated. The 
number of subjects attending each scheduled visit, discontinuing study medication prior to 
Day 28, terminating the study, reasons for early termination and time from randomization to 
study termination will be tabulated. The number of subjects considered screen failures and 
reason for screen failure will be tabulated.  The number of subjects failing to meet any 
inclusion or exclusion criterion will be tabulated. 
 
7.3 Baseline Characteristics 
Baseline demographic data will be summarized. 
 
7.3.1 Medical History 
Tabulations of previous and ongoing conditions at screening will be presented by randomized 
treatment group and overall. Medical history marked as Ongoing status as ‘No’ or with an end 
date prior to the date of randomization is considered previous. Medical history marked as 
Ongoing status as ‘Yes’ or an end date on or after the date of randomization are considered 
as concurrent disease.  Conditions will be presented by MedDRA primary system organ class 
and preferred term. 
7.3.2 Concomitant medication  
Prior medication refers to any medication that was stopped prior to the day of randomization. 
Concomitant medication refers to the new use or ongoing use of a medication at the 
randomization date up to and including the date of study termination.   
Separate tabulations will be produced for prior or concomitant medications presented by 
randomized treatment group and overall for the Safety Analysis Set. Concomitant 
medications will be summarized using Anatomic Therapeutic Chemical (ATC) Level 2. 
 
Additionally, the number and percentage of subjects taking any medication in the following 
categories will be tabulated. Cardiovascular and non-cardiovascular treatments will also be 
tabulated separately. 
- beta-blocker 
- ACE-inhibitor 
- diuretic 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 18 
- insulin or angiotensin receptor blocker (ARB) 
- antibiotic or antiviral Rx 
- corticosteriod 
 
7.3.3 Physical Examination 
Physical examination results will be listed. 
 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 19 
8 COMPLIANCE WITH STUDY MEDICATION AND DRUG 
ACCOUNTABILITY 
 
For each visit the number of patients who were continued on any dose of study medication 
will be summarized. 
In addition, drug accountability will be calculated for each visit. 
Compliance at Visit x:  
[(Total amount of IP dispensed at visit x [initial weight of all bottles dispensed] – Total 
amount of IP returned for bottles dispensed at visit x [weight of all bottles returned]) / Total 
amount of IP dispensed at visit x]*100. 
 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 20 
9 EVALUATION OF EFFICACY AND SAFETY 
9.1 Primary Analysis for Efficacy 
The primary efficacy outcome is the percent of patients who experience one of the following 
events during the first 28 days: 
 
o All-cause mortality 
o Requirement for ICU admission and/or ventilatory support 
o CV complications*:  
o HF or  
o AMI or 
o Myocarditis or 
o new sustained or symptomatic arrhythmia or 
o stroke 
 
*Outcome definitions can be found in Appendix 17.8 of the study protocol. 
 
 
9.1.1 Proportions of Subjects with an Event 
All subjects who have met any condition of the composite outcome will be listed.  
 
Due to the early termination of the study no analysis will be performed.   
9.2 Secondary Efficacy Analyses 
Due to the early termination of the study the Win Ratio of the Ordinal Outcome scale will not 
be generated. Ordinal outcome scale scores will be listed and summarized for each visit.   
 
The change from baseline in each biomarker (hs-troponin, NT-proBNP, D-dimer) and 
inflammatory marker (hs-CRP, ferritin, IL-1 beta, IL-6, IL-10) over time will be summarized 
at each time point and graphically displayed.  After review of the profiles over time, the 
following parameters may be calculated. 
 
Emax 7 
Maximum post-baseline change* 
(baseline-corrected change) up to the 
time of the Day 7 assessment; reported 
to 2 decimal places.  
Emax 28 
Maximum post-baseline change* 
(baseline-corrected change) up to the 
time of the Day 28 assessment; reported 
to 2 decimal places.  
AUEC0-7 
Area under the change from baseline 
curve from time zero to the Day 7 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 21 
assessment; calculated using the linear 
trapezoidal rule; reported to 3 significant 
figures.  
AUEC0-28 
Area under the change from baseline 
curve from time zero to the Day 28 
assessment; calculated using the linear 
trapezoidal rule; reported to 3 significant 
figures. 
 
 
*maximum post-baseline change will be positive for biomarkers that increase relative to 
baseline over the time interval; or negative for those that decrease relative to baseline. 
 
Assumptions for AUEC calculation:  
 
• Time points other than pre-dose will use actual time point instead of nominal time points. If 
actual assessment time is missing the nominal time will be used.  
• Values missing at time points after baseline and prior to last time point in the interval will 
not be imputed.  
• If data at last time point is missing, AUEC will be calculated up to latest non-missing time 
point.  
• AUEC calculation will not include unscheduled and repeat measurements. 
 
 
Comparison of each parameter between the two treatment groups using an ANCOVA with 
fixed factors for treatment and the baseline value as covariate will be performed. 
 
 
9.3 Other Efficacy and Safety Analyses 
9.3.1 Binary Outcomes 
Subjects with an event will be listed for the following outcomes: 
 
- 
any one of the primary endpoint components within 60 days post randomization 
- 
CV mortality at 28 days post randomization 
 
9.3.2 Columbia Suicide Severity Rating Scale (C-SSRS) 
To monitor for the emergence of suicidal ideation and behavior, subjects will undergo C-
SSRS evaluations at baseline and at Day 28. 
The number of subjects experiencing suicidal Ideation or suicidal behavior will be 
summarized.  Shift tables in relation to suicidal ideation and/or behavior from baseline to 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 22 
Day 28 will be presented. 
 
There will be no imputation of missing data for C-SSRS. 
 
9.3.3 Patient Impression of Change Questionnaire (PICQ) 
The patient will be asked to document how her/his overall status changed.  
 
Data will be listed. 
 
9.3.4 Laboratory Tests 
For laboratory (Local Laboratory) data both scheduled and unscheduled post-baseline values 
will be tabulated. Descriptive statistics of the observed values and change from baseline 
(continuous data) will be presented by treatment group and visit for each parameter.  
 
Each measurement (continuous data) will be classed as low(below normal range), normal ( 
within normal range), or high (above normal range), based on ranges supplied by the 
laboratory used. Shift tables in relation to the normal range from baseline to each post 
Baseline visit will be presented. 
 
As normal range for these assays may depend on gender, when applicable, data will be 
tabulated separately for men and women when applicable. 
 
Additionally, a summary of targeted parameters against specified threshold limits will be 
presented. 
 
9.3.5 Vital Signs  
Descriptive statistics of the observed values and change from baseline (continuous data) will 
be presented by treatment group and visit for each parameter.  
 
9.3.6 ECG  
Available standard ECG data will be tabulated by treatment group for each visit. Descriptive 
statistics of the observed values and change from baseline (continuous data) will be 
presented by treatment group and visit for parameter. Each visit will be assessed as 
Normal/Abnormal and Clinically Significant/Not Clinically Significant. Shift tables in relation 
to the combined status from baseline to each post Baseline visit will be presented. 
9.3.7 Chest X-Ray 
Each visit will be assessed as Normal/Abnormal. Shift tables in relation to the combined 
status from baseline to each post Baseline visit will be presented. 
 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 23 
9.3.8 Adverse Events 
Adverse events are to be recorded throughout the study, beginning at the moment of 
informed consent. AEs will be coded using MedDRA and displayed in tables and listings by 
System Organ Class (SOC) and Preferred Term (PT). 
 
Analyses of adverse events will be performed for those events that are considered 
treatment-emergent, where a treatment-emergent AE (TEAE) is defined as one that started, 
or worsened in severity or seriousness following the first dose of IMP. An AE with onset 
prior to the start of the administration of the first dose of study drug, or where the stop date 
is before the start of the administration of the first dose of study drug, or where the study 
drug was not started, will be considered as pre-study. In case the onset date is on the same 
day as the first dose of study drug and either the time of first dose or time of AE onset is 
missing, then AE is considered treatment-emergent. 
 
AE intensity will be qualified as mild, moderate, or severe. Maximum severity will be 
assumed for an AE with missing severity. The relationship to the study drug will be qualified 
as related (including categories related, probably, possibly) or unrelated. 
If the AE start date is missing or partial, the AE will be assigned to the appropriate period 
using available start date information and the stop date, if present as described above. 
 
The following tables will be presented for AEs incidence and/or number of events will be 
reported as appropriate: 
x Overall summary of AEs 
x TEAEs by system organ class and preferred term 
x Treatment related TEAEs by system organ class and preferred term 
x Serious TEAEs by system organ class and preferred term 
x TEAEs by system organ class, preferred term and maximum severity 
x TEAEs leading to study drug discontinuation by system organ class and preferred term 
x Listing of AEs  
x Listing of Serious TEAEs  
x Listing of AESIs  
x Listing of Deaths  
Adverse event incidence is counted only once per system organ class and once per preferred 
term. The number and percent of subjects experiencing events are reported.  Outputs 
reported at maximum severity show the highest severity reported by a patient per system 
organ class and preferred term.  
 
 
 
 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 24 
10 CHANGES TO PLANNED ANALYSES 
Due to the early termination of the study no inferential testing will be performed.  All 
summaries will be presented descriptively.  Limited scope reporting is described above. 
 


 
 
PROPRIETARY AND CONFIDENTIAL 
 
 
LANCER Study SAP version 1.0 19JAN2023 
 
Page 25 
11 REFERENCES 
1.  SAS Institute Inc., Cary, NC, 27513, USA 
 


Certificate Of Completion
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