Trial Outcomes & Findings for A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants (NCT NCT05371652)

NCT ID: NCT05371652

Last Updated: 2025-02-20

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

241 participants

Primary outcome timeframe

From Day 1 of study treatment up to Week 52 of the treatment safety period

Results posted on

2025-02-20

Participant Flow

A total of 241 participants were enrolled in the study. 240 participants received study treatment.

Participant milestones

Participant milestones
Measure	Rimegepant 75 Milligrams (mg) Orally Disintegrating Tablets (ODT) Chinese participants with migraine received 75 mg of rimegepant ODT (Pro re nata \[PRN\] use, up to 1 tablet per day) for 52 weeks.
Overall Study STARTED	241
Overall Study Treated	240
Overall Study COMPLETED	208
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Rimegepant 75 Milligrams (mg) Orally Disintegrating Tablets (ODT) Chinese participants with migraine received 75 mg of rimegepant ODT (Pro re nata \[PRN\] use, up to 1 tablet per day) for 52 weeks.
Overall Study Non-Compliance with Study Schedule	9
Overall Study Withdrawal by Subject	12
Overall Study Adverse Event	1
Overall Study Other	11

Baseline Characteristics

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rimegepant 75mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Age, Continuous	39.1 Years STANDARD_DEVIATION 10.97 • n=5 Participants
Sex: Female, Male Female	192 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	240 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Han	231 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set (SS) included all participants who received at least one dose of investigational product.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	203 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: Follow-up safety analysis set (FUSS) included all participants in the SS with last contact date in the follow-up safety analysis period.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=228 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With TEAEs	24 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set included all participants who received at least one dose of investigational product.

An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. SAE referred to any untoward medical occurrence that met any of the following criteria at any dose for a participant that received the investigational product: death, life-threatening, permanent or severe disability or incapacity, hospitalization or prolongation of hospitalization required or congenital anomaly or birth defect.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs)	7 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: FUSS included all participants in the SS with last contact date in the follow-up safety analysis period.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=228 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With SAEs	0 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set included all participants who received at least one dose of investigational product.

An AE was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily had a causal relationship with the investigational product. AEs that led to study drug discontinuation were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation	1 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: FUSS included all participants in the SS with last contact date in the follow-up safety analysis period.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=228 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation	0 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set included all participants who received at least one dose of investigational product.

ECG abnormalities criteria included: QT Interval Corrected Using Fridericia's Formula (QTcF) millisecond (msec): less than or equal to (\<=)450, 450 - \<=480, 480- \<=500, greater than (\>)500.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities <=450	225 Participants
Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities 450 - <= 480	6 Participants
Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities 480 - <= 500	0 Participants
Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities > 500	0 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: FUSS included all participants in the SS with last contact date in the follow-up safety analysis period.

ECG abnormalities criteria included: QTcF msec: \<=450, 450 - \<=480, 480- \<=500, \>500.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=228 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With ECG Abnormalities <=450	209 Participants
Follow-up Safety Period: Number of Participants With ECG Abnormalities 450 - <= 480	2 Participants
Follow-up Safety Period: Number of Participants With ECG Abnormalities 480 - <= 500	0 Participants
Follow-up Safety Period: Number of Participants With ECG Abnormalities >500	2 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set included all participants who received at least one dose of investigational product. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Vital signs abnormalities included blood pressure (BP) millimeters of mercury (mmHg): systolic BP \<90 and \>140; diastolic BP \<50 and \>90 and pulse rate (beats per minute) :\<40 and \>120.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=238 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Systolic BP <90	12 Participants
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Systolic BP >140	9 Participants
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Diastolic BP <50	1 Participants
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Diastolic BP >90	17 Participants
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Pulse rate <40	0 Participants
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Pulse rate >120	0 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Vital signs abnormalities included BP mmHg: systolic BP \<90 and \>140; diastolic BP \<50 and \>90 and pulse rate (beats per minute) :\<40 and \>120.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=213 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Systolic BP <90	1 Participants
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Systolic BP >140	1 Participants
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Diastolic BP <50	0 Participants
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Diastolic BP >90	5 Participants
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Pulse rate <40	0 Participants
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Pulse rate >120	0 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set included all participants who received at least one dose of investigational product.

Hematology parameters included: hemoglobin increased, anemia, leukocytosis, white blood cell decreased, platelet count decreased, neutrophil count decreased, lymphocyte count increased, lymphocyte count decreased. As per National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version(v)5.0-Grade(G) 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL), Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. Grade 3 and 4 abnormalities were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Hemoglobin increased	0 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Anemia	1 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Leukocytosis	0 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities White blood cell decreased	1 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Platelet count decreased	0 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Neutrophil count decreased	1 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Lymphocyte count increased	0 Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Lymphocyte count decreased	1 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: FUSS included all participants in the SS with last contact date in the follow-up safety analysis period.

Hematology parameters included: hemoglobin increased, anemia, leukocytosis, white blood cell decreased, platelet count decreased, neutrophil count decreased, lymphocyte count increased, lymphocyte count decreased. As per NCI CTCAE v5.0-Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. Grade 3 and 4 abnormalities were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=228 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Hemoglobin increased	0 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Anemia	0 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Leukocytosis	0 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities White blood cell decreased	0 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Platelet count decreased	0 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Neutrophil count decreased	1 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Lymphocyte count increased	0 Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Lymphocyte count decreased	0 Participants

PRIMARY outcome

Timeframe: From Day 1 of study treatment up to Week 52 of the treatment safety period

Population: Safety analysis set included all participants who received at least one dose of investigational product.

Chemistry Test Abnormalities included: hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypoglycemia, creatinine increased, blood lactate dehydrogenase increased, hypoalbuminemia, creatine phosphokinase (CPK) increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, alkaline phosphatase increased, chronic kidney disease, cholesterol high, hypertriglyceridemia. As per NCI CTCAE v5.0-G1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, G2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, G3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. G3 and 4 abnormalities were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hypernatremia	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hyponatremia	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hyperkalemia	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hypokalemia	1 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hypoglycemia	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Creatinine increased	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Blood lactate dehydrogenase increased	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hypoalbuminemia	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities CPK increased	4 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Aspartate aminotransferase increased	1 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Alanine aminotransferase increased	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Blood bilirubin increased	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Alkaline phosphatase increased	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Chronic kidney disease	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Cholesterol high	0 Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities Hypertriglyceridemia	2 Participants

PRIMARY outcome

Timeframe: From Week 52 to Week 54 of the follow-up safety period

Population: FUSS included all participants in the SS with last contact date in the follow-up safety analysis period.

Chemistry Test Abnormalities included: hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypoglycemia, creatinine increased, blood lactate dehydrogenase increased, hypoalbuminemia, CPK increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, alkaline phosphatase increased, chronic kidney disease, cholesterol high, hypertriglyceridemia. As per NCI CTCAE v5.0-G1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, G2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, G3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. G4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. G3 and 4 abnormalities were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=228 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hypernatremia	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hyponatremia	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hyperkalemia	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hypokalemia	1 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hypoglycemia	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Creatinine increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Blood lactate dehydrogenase increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hypoalbuminemia	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities CPK increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Aspartate aminotransferase increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Alanine aminotransferase increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Blood bilirubin increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Alkaline phosphatase increased	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Chronic kidney disease	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Cholesterol high	0 Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities Hypertriglyceridemia	0 Participants

SECONDARY outcome

Timeframe: Baseline (observation period); Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52 and Overall (Week 1 to 52)

Population: Efficacy analysis set (EAS) included all participants in the FAS with\>= 14 electronic (e)Diary days (not necessarily consecutive) in both the observational period analysis period and\>= 1 month (4-week interval) of the long-term treatment analysis period. "Number Analyzed" signifies number of participants evaluable for the specified rows.

The number of migraine days and severity of migraine attacks was analyzed for every 4-week interval and overall period during long-term treatment with rimegepant in participants was compared to the observation period. Pain intensity of migraine was graded into mild, moderate, or severe and severity was judged by investigator.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg ODT n=240 Participants Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 1 to Week 4	-1.7 Days Standard Deviation 3.8
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 5 to Week 8	-2.4 Days Standard Deviation 4.5
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 9 to Week 12	-3.4 Days Standard Deviation 4.2
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 13 to Week 16	-3.7 Days Standard Deviation 4.6
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 17 to Week 20	-4.4 Days Standard Deviation 4.6
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 21 to Week 24	-4.8 Days Standard Deviation 4.6
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 25 to Week 28	-5.2 Days Standard Deviation 4.6
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 29 to Week 32	-4.8 Days Standard Deviation 4.7
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 33 to Week 36	-5.2 Days Standard Deviation 4.5
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 37 to Week 40	-5.5 Days Standard Deviation 5.1
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 41 to Week 44	-5.7 Days Standard Deviation 4.7
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 45 to Week 48	-5.6 Days Standard Deviation 4.7
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Week 49 to Week 52	-5.6 Days Standard Deviation 5.5
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period Overall	-2.8 Days Standard Deviation 4.1

Adverse Events

Rimegepant 75 mg ODT

Serious events: 7 serious events

Other events: 201 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Rimegepant 75 mg ODT n=240 participants at risk Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Cardiac disorders Arteriosclerosis coronary artery	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Pneumonia	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Injury, poisoning and procedural complications Clavicle fracture	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Nervous system disorders Brain injury	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Vascular disorders Varicose vein	0.42% 1/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.

Other adverse events

Other adverse events
Measure	Rimegepant 75 mg ODT n=240 participants at risk Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks.
Infections and infestations COVID-19	41.7% 100/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Upper respiratory tract infection	11.7% 28/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Nasopharyngitis	7.1% 17/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Urinary tract infection	2.9% 7/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Influenza	2.5% 6/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Pharyngitis	2.5% 6/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Infections and infestations Respiratory tract infection	2.5% 6/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Metabolism and nutrition disorders Hyperuricaemia	7.5% 18/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Metabolism and nutrition disorders Hyperlipidaemia	6.7% 16/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Investigations Weight increased	4.6% 11/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Investigations Weight decreased	3.8% 9/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Investigations Alanine aminotransferase increased	2.9% 7/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Investigations Aspartate aminotransferase increased	2.5% 6/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Investigations Blood creatine phosphokinase increased	2.1% 5/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.2% 10/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 9/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Cardiac disorders Sinus arrhythmia	3.8% 9/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Cardiac disorders Sinus bradycardia	2.5% 6/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
General disorders Pyrexia	5.4% 13/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Hepatobiliary disorders Hepatic function abnormal	4.2% 10/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Blood and lymphatic system disorders Anaemia	3.8% 9/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Gastrointestinal disorders Toothache	3.3% 8/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
Psychiatric disorders Insomnia	2.5% 6/240 • From Day 1 of study treatment up to Week 54 Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER