Trial Outcomes & Findings for Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065) (NCT NCT01125774)

NCT ID: NCT01125774

Last Updated: 2018-10-23

Results Overview

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 4548 participants
• Primary outcome timeframe: Up to 14 days after the last dose of study drug (Up to 6.5 months)
• Results posted on: 2018-10-23

Participant Flow

Participants were randomized to telcagepant 140 mg or placebo. Protocol deviation occurred in which 28 participants (called "duplicate participants") were randomized at more than 1 study site (22 unique participants randomized in total 37 times to telcagepant and 12 times to placebo; 6 unique participants randomized in total 12 times to placebo)

Participant milestones

Measure	Telcagepant 140 mg - Excluding Duplicate Participants Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo - Excluding Duplicate Participants Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Telcagepant 140 mg - Duplicate Participants Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo - Duplicate Participants Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Overall Study STARTED	3018	1502	22	6
Overall Study Treated	2638	1322	21	5
Overall Study COMPLETED	1893	948	13	3
Overall Study NOT COMPLETED	1125	554	9	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

Baseline characteristics by cohort

Measure	Telcagepant 140 mg n=3040 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1508 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Total n=4548 Participants Total of all reporting groups
Age, Continuous	36.1 Years STANDARD_DEVIATION 8.6 • n=5 Participants	35.8 Years STANDARD_DEVIATION 8.7 • n=7 Participants	36.0 Years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	3040 Participants n=5 Participants	1508 Participants n=7 Participants	4548 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days after the last dose of study drug (Up to 6.5 months)

Population: All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.

Outcome measures

Measure	Telcagepant 140 mg n=2660 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1326 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Number of Participants With Clinical Adverse Events (AEs)	1582 Participants 0.19	804 Participants 0.26

PRIMARY outcome

Timeframe: Up to 6 months

Population: APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.

Outcome measures

Measure	Telcagepant 140 mg n=2660 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1326 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Number of Participants Who Discontinued Study Due to a Clinical AE	66 Participants 0.19	36 Participants 0.26

PRIMARY outcome

Timeframe: Up to 6 months

Population: APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.

Outcome measures

Measure	Telcagepant 140 mg n=2610 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1305 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Number of Participants With Laboratory AEs	76 Participants 0.19	30 Participants 0.26

PRIMARY outcome

Timeframe: Up to 6 months

Population: APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.

Outcome measures

Measure	Telcagepant 140 mg n=2610 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1305 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Number of Participants Who Discontinued Study Due to a Laboratory AE	8 Participants 0.19	2 Participants 0.26

PRIMARY outcome

Timeframe: Up to 6 months

Population: All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.

Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.

Outcome measures

Measure	Telcagepant 140 mg n=887 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=447 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	8.8 Days per month Standard Error 0.19	9.3 Days per month Standard Error 0.26

SECONDARY outcome

Timeframe: Up to 6 months

Population: All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.

Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.

Outcome measures

Measure	Telcagepant 140 mg n=731 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=382 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	9.3 Days per month Standard Error 0.20	9.6 Days per month Standard Error 0.28

SECONDARY outcome

Timeframe: Up to 6 months

Population: All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.

Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.

Outcome measures

Measure	Telcagepant 140 mg n=887 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=448 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	2.5 Days per month Standard Error 0.05	2.9 Days per month Standard Error 0.08

SECONDARY outcome

Timeframe: Up to 6 months

Population: All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.

Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.

Outcome measures

Measure	Telcagepant 140 mg n=731 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=383 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	2.6 Days per month Standard Error 0.06	3.0 Days per month Standard Error 0.08

SECONDARY outcome

Timeframe: Up to 6 months

Population: All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.

Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.

Outcome measures

Measure	Telcagepant 140 mg n=344 Participants Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=151 Participants Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline	2.1 Days per month Standard Error 0.08	2.2 Days per month Standard Error 0.12

Adverse Events

Telcagepant 140 mg

Serious events: 25 serious events

Other events: 819 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 413 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telcagepant 140 mg n=2660 participants at risk Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1326 participants at risk Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Cardiac disorders Cardiac arrest	0.04% 1/2660 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Cardiac disorders Myocardial infarction	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Gastrointestinal disorders Pancreatitis	0.08% 2/2660 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
General disorders Chest pain	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Hepatobiliary disorders Cholelithiasis obstructive	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Immune system disorders Anaphylactic reaction	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Immune system disorders Hypersensitivity	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Infections and infestations Cellulitis	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Infections and infestations Cervicitis	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Injury, poisoning and procedural complications Contusion	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Injury, poisoning and procedural complications Traumatic brain injury	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Investigations Alanine aminotransferase increased	0.11% 3/2660 • Number of events 3 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Investigations Aspartate aminotransferase increased	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Metabolism and nutrition disorders Hypocalcaemia	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Metabolism and nutrition disorders Hypokalaemia	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Metabolism and nutrition disorders Hyponatraemia	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Metabolism and nutrition disorders Metabolic acidosis	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Nervous system disorders Cervicobrachial syndrome	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Nervous system disorders Migraine with aura	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Nervous system disorders Post-traumatic headache	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Nervous system disorders VIIth nerve paralysis	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Pregnancy, puerperium and perinatal conditions Umbilical cord prolapse	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Psychiatric disorders Acute stress disorder	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Psychiatric disorders Anxiety	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Psychiatric disorders Depression	0.08% 2/2660 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Psychiatric disorders Mental status changes	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Psychiatric disorders Suicidal ideation	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Renal and urinary disorders Calculus urinary	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2660 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.08% 1/1326 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Renal and urinary disorders Renal failure	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Reproductive system and breast disorders Endometriosis	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Respiratory, thoracic and mediastinal disorders Asthma	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Respiratory, thoracic and mediastinal disorders Non-cardiogenic pulmonary oedema	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.04% 1/2660 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	0.00% 0/1326 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.

Other adverse events

Measure	Telcagepant 140 mg n=2660 participants at risk Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.	Placebo n=1326 participants at risk Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Gastrointestinal disorders Diarrhoea	7.0% 186/2660 • Number of events 292 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	6.8% 90/1326 • Number of events 128 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Gastrointestinal disorders Dry mouth	6.5% 174/2660 • Number of events 359 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	6.4% 85/1326 • Number of events 168 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Gastrointestinal disorders Nausea	10.2% 270/2660 • Number of events 467 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	12.4% 165/1326 • Number of events 264 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
General disorders Fatigue	5.1% 135/2660 • Number of events 194 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	4.9% 65/1326 • Number of events 130 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Infections and infestations Nasopharyngitis	7.1% 190/2660 • Number of events 226 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	7.7% 102/1326 • Number of events 122 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.
Nervous system disorders Dizziness	7.7% 204/2660 • Number of events 340 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.	7.5% 100/1326 • Number of events 166 • Up to 14 days after the last dose of study drug (Up to 6.5 months) APaT population, which included all randomized participants who took at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm. Presentation includes clinical and laboratory AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER