Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg f... | NCT04574362

ID	Type	Description	Link
C4951026	Other Identifier	Alias Study Number

Status Module

Name	Class
BioShin Limited	INDUSTRY

Label	Type	Description	Intervention Names
Rimegepant 75mg	Active Comparator	One 75mg oral disintegration tablet	Drug: Rimegepant
Placebo	Placebo Comparator	Matching placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Rimegepant	Drug	One 75mg orally disintegrating tablet	Rimegepant 75mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose	Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Exact 95 percent (%) confidence interval (CI) was based on Clopper-Pearson method.	2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose	MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. Exact 95% CI was based on Clopper-Pearson method.	2 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Pain Relief at 2 Hours Post-dose	Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants who reported a pain level of moderate or severe at baseline and then reported a pain level of none or mild at 2 hours post-dose, were considered to have pain relief. Exact 95% CI was based on Clopper-Pearson method.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version including the following:

Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
Migraine attacks, on average, lasting about 4-72 hours if untreated
Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.
Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Subject with a history of HIV disease
Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
Subjects are excluded if they have previously participated in any study of rimegepant or other experimental CGRP-antagonist study, or have been prescribed CGRP-antibodies within the last 6 months
Participation in any other investigational clinical trial while participating in this clinical trial

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Bengbu Medical College		Bengbu	Anhui	233030	China
Anhui provincal Hospital

PubMed Identifier	Type	Citation	Retractions
38627638	Derived	Yu S, Guo A, Wang Z, Liu J, Tan G, Yang Q, Zhang M, Yibulaiyin H, Chen H, Zhang Y, Croop R, Sun Y, Liu Y, Zhao Q, Lu Z. Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial. J Headache Pain. 2024 Apr 16;25(1):57. doi: 10.1186/s10194-024-01731-4.
37210098

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rimegepant 75 Milligram (mg)	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to 7 days post-dose.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 25, 2021	Mar 8, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose

Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Exact 95 percent (%) confidence interval (CI) was based on Clopper-Pearson method.

Modified intent to treat (mITT) participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.

Posted

Number

95% Confidence Interval

Percentage of participants

2 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants	OG000666 OG001674

Title

Denominators

Categories

Title	Measurements
	OG00019.8(16.9 to 23.1) OG00110.7(8.5 to 13.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<0.0001		Risk Difference (RD)	9.2			2-Sided	95	5.4	13.0			Risk difference and associated 95 percent (%) confidence interval (CI) were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.		Superiority

Primary

Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose

MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

2 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants With Pain Relief at 2 Hours Post-dose

Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants who reported a pain level of moderate or severe at baseline and then reported a pain level of none or mild at 2 hours post-dose, were considered to have pain relief. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

2 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants Who Functioned Normally at 2 Hours Post-dose

Participants rated the level of disability they perceived as a result of their migraine in performing normal actions using following level of severity: normal function, mild impairment, severe impairment, or required bedrest. This outcome measure was analyzed only among those participants who reported any impairment at baseline. Percentage of participants with a response of "normal function" at the 2 hours post-dose were reported in this outcome measure.

mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

2 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Secondary

Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose

Percentage of participants who used rescue medications within 24 hours of administration of study drug were reported in this outcome measure. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

24 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose

Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

2 to 24 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose

Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

2 to 48 hours post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose

Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Percentage of participants who reported a pain level of moderate or severe just before taking study treatment and then reported a pain level of none at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

15, 30, 45, 60 and 90 minutes post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose

MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

15, 30, 45, 60 and 90 minutes post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Units	Counts
Participants

Secondary

Percentage of Participants With Pain Relapse

Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. This outcome measure was analyzed only in those participants who were pain free at 2 hours post-dose. Percentage of participants who were pain free at 2 hours post-dose and then had a migraine of any pain severity (score 2 or 3 on the 4-point scale) within 48 hours after administration of study drug were considered to have pain relapse. Exact 95% CI was based on Clopper-Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

2 Hours to 48 Hours Post-dose

ID	Title	Description
OG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
OG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Protein urine present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected668 at risk EG0017 affected674 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected668 at risk EG0013 affected674 at risk
Blood urine present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected668 at risk EG0012 affected674 at risk
Blood glucose increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected668 at risk EG0011 affected674 at risk
Urine leukocyte esterase positive	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected668 at risk EG0011 affected674 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0012 affected674 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0011 affected674 at risk
Urine ketone body present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0011 affected674 at risk
Blood pressure increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
Hepatic enzyme increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0012 affected674 at risk
Neutrophil count decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
Nitrite urine present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
Platelet count decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Urine analysis abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Weight increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
White blood cells urine positive	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
Blood bicarbonate decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Blood bilirubin increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Blood creatine phosphokinase MM increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Blood uric acid abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Blood uric acid increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Crystal urine present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Electrocardiogram T wave amplitude decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Glucose urine present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Weight decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
White blood cell count decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected668 at risk EG00118 affected674 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0014 affected674 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0012 affected674 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Dry mouth	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Gingival pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected668 at risk EG0018 affected674 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected668 at risk EG0014 affected674 at risk
Gingivitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
Folliculitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Paronychia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Pharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Vaginal infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0015 affected674 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Erythropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0013 affected674 at risk
Palpitations	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Bradycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0012 affected674 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0011 affected674 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected668 at risk EG0011 affected674 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0011 affected674 at risk
Albuminuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Photophobia	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected668 at risk EG0013 affected674 at risk
Dizziness	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0012 affected674 at risk
Burning sensation	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Tremor	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0012 affected674 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0012 affected674 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0012 affected674 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Chills	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0012 affected674 at risk
Asthenia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0011 affected674 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected668 at risk EG0010 affected674 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Insomnia	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Phonophobia	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Abortion induced	Surgical and medical procedures	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0011 affected674 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Drug hypersensitivity	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Title	Description
BG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.
BG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rimegepant 75 mg	Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.	0	668	1	668	92	668
EG001	Placebo	Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose.	0	674	2	674	94	674

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemoperitoneum	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected668 at risk EG0010 affected674 at risk
Decreased embryo viability	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected668 at risk EG0011 affected674 at risk