A Phase I, Open-Label, Multiple-Dose Study of the Effect of Evobrutinib on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Participants
Phase: PHASE1
Conditions: Healthy
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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Evobrutinib (M2951) 
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral 
MS200527_0079 
Contraceptive 
 
 
C O N F I D E N T I A L 
I N F O R M A T I O N 
5/70 
 
 
8.3.2 
Follow-up of Adverse Events and Serious Adverse Events ...............35 
8.3.3 
Regulatory Reporting Requirements for Serious Adverse Events .....35 
8.3.4 
Pregnancy ...........................................................................................36 
8.3.5 
Cardiovascular and Death Events .......................................................36 
8.3.6 
Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs ................................................................37 
8.3.7 
Adverse Events of Special Interest .....................................................37 
8.4 
Pharmacokinetics ................................................................................38 
8.5 
Pharmacogenetics ...............................................................................39 
8.6 
Biomarkers ..........................................................................................39 
8.7 
Immunogenicity Assessments ............................................................39 
8.8 
Health Economics ...............................................................................40 
9 
Statistical Considerations ....................................................................40 
9.1 
Statistical Hypotheses .........................................................................40 
9.2 
Sample Size Determination ................................................................40 
9.3 
Analyses Sets ......................................................................................43 
9.4 
Statistical Analyses .............................................................................43 
9.4.1 
Efficacy Analyses ...............................................................................44 
9.4.2 
Safety Analyses ..................................................................................44 
9.4.3 
Other Analyses ....................................................................................44 
9.4.3.1 
Analysis of Pharmacokinetics .............................................................44 
9.4.4 
Sequence of Analyses .........................................................................45 
10 
References ...........................................................................................46 
11 
Appendices .........................................................................................48 
Appendix 1 
Abbreviations ......................................................................................49 
Appendix 2 
Study Governance ...............................................................................51 
Appendix 3 
Contraception and Barrier Requirements ...........................................57 
Appendix 4 
Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ................................................58 
Appendix 5 
Clinical Laboratory Tests ...................................................................65 
Appendix 6 
Pharmacogenetics ...............................................................................66 
Appendix 7 
Protocol Amendment History .............................................................67 
Appendix 8 
Sponsor Signature Page ......................................................................69 
Global Version ID: 78691_4386013_5448988
Global Version ID: 78691_4394742_5846157

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Evobrutinib (M2951) 
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral 
MS200527_0079 
Contraceptive 
 
 
C O N F I D E N T I A L 
I N F O R M A T I O N 
47/70 
 
 
Zhang N, Shon J, Kim M-J, et al. Role of CYP3A in Oral Contraceptives Clearance. Clin Transl 
Sci. 2018;11:251-260.  
Global Version ID: 78691_4386013_5448988
Global Version ID: 78691_4394742_5846157

Evobrutinib (M2951) 
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral 
MS200527_0079 
Contraceptive 
 
 
C O N F I D E N T I A L 
I N F O R M A T I O N 
48/70 
 
 
11 
Appendices  
Global Version ID: 78691_4386013_5448988
Global Version ID: 78691_4394742_5846157

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Evobrutinib (M2951) 
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral 
MS200527_0079 
Contraceptive 
 
 
C O N F I D E N T I A L 
I N F O R M A T I O N 
61/70 
 
 
 
Assessment of Intensity 
The Investigator will assess the intensity of each AE and SAE reported during the study and 
assign it to 1 of the following categories: 
• Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not 
interfering with everyday activities. 
• Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• Severe: An event that prevents normal everyday activities. Do not confuse an AE that is 
assessed as severe with a SAE. Severe is a category used to rate the intensity of an event; 
both AEs and SAEs can be assessed as severe. 
An event is defined as “serious” when it meets at least 1 of the predefined criteria specified 
in the definition of an SAE, NOT when it is rated as severe. 
 
Assessment of Causality 
• The Investigator will assess the relationship between study intervention and each AE/SAE 
occurrence: 
o Unrelated: Not reasonably related to the study intervention. AE could not medically 
(pharmacologically/clinically) be attributed to the study intervention. A reasonable 
alternative explanation will be available. 
o Related: Reasonably related to the study intervention. AE could medically 
(pharmacologically/clinically) be attributed to the study intervention. 
• A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• The Investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated. 
• The Investigator will also consult the IB and/or Product Information, for marketed 
products, in his/her assessment. 
• For each AE/SAE, the Investigator will document in the medical notes that he/she has 
reviewed the AE/SAE and assessed causality. 
• There may be situations when an SAE has occurred, and the Investigator has minimal 
information to include in the initial report to the Sponsor or its designee. To meet the 
reporting timeline, the causality assessment is not required for the initial report. 
• The Investigator may change his/her causality assessment after considering follow-up 
information and send a SAE follow-up report with the updated causality assessment. 
Global Version ID: 78691_4386013_5448988
Global Version ID: 78691_4394742_5846157

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