Trial Outcomes & Findings for Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016) (NCT NCT00432237)

NCT ID: NCT00432237

Last Updated: 2015-07-03

Results Overview

Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1703 participants
• Primary outcome timeframe: 2 hours post dose
• Results posted on: 2015-07-03

Participant Flow

There were 83 centers worldwide that participated: United States (36), Latin America (9), and Europe (38). First Patient Treated = 25 March 2007, and Last Patient Last Treatment = 29 November 2007.

Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.

Participant milestones

Measure	MK0974 50 mg MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 150 mg MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	Placebo Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Study STARTED	244	485	484	490
Overall Study Completed--With Data	176	381	370	365
Overall Study Completed--No Data	1	3	5	1
Overall Study COMPLETED	177	384	375	366
Overall Study NOT COMPLETED	67	101	109	124

Reasons for withdrawal

Measure	MK0974 50 mg MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 150 mg MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	Placebo Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Overall Study Adverse Event	0	0	0	1
Overall Study Lack of Efficacy	0	0	0	1
Overall Study Lost to Follow-up	10	10	18	18
Overall Study Physician Decision	1	3	2	1
Overall Study Pregnancy	0	1	0	0
Overall Study Protocol Violation	13	10	11	8
Overall Study Withdrawal by Subject	5	6	9	11
Overall Study Lack of Qualifying Event	38	71	69	84

Baseline Characteristics

Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

Baseline characteristics by cohort

Measure	MK0974 50 mg n=177 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study.	MK0974 150 mg n=381 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study.	MK0974 300 mg n=371 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study.	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study.	Total n=1294 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 11.3 • n=93 Participants	41.6 years STANDARD_DEVIATION 11.0 • n=4 Participants	41.8 years STANDARD_DEVIATION 11.6 • n=27 Participants	41.9 years STANDARD_DEVIATION 11.9 • n=483 Participants	41.7 years STANDARD_DEVIATION 11.5 • n=36 Participants
Sex: Female, Male Female	156 Participants n=93 Participants	329 Participants n=4 Participants	320 Participants n=27 Participants	318 Participants n=483 Participants	1123 Participants n=36 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	52 Participants n=4 Participants	51 Participants n=27 Participants	47 Participants n=483 Participants	171 Participants n=36 Participants
Race/Ethnicity, Customized White	148 participants n=93 Participants	320 participants n=4 Participants	302 participants n=27 Participants	303 participants n=483 Participants	1073 participants n=36 Participants
Race/Ethnicity, Customized Black	10 participants n=93 Participants	16 participants n=4 Participants	23 participants n=27 Participants	20 participants n=483 Participants	69 participants n=36 Participants
Race/Ethnicity, Customized Asian	1 participants n=93 Participants	6 participants n=4 Participants	1 participants n=27 Participants	8 participants n=483 Participants	16 participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=93 Participants	2 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	3 participants n=36 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
Race/Ethnicity, Customized Multi-Racial	17 participants n=93 Participants	37 participants n=4 Participants	44 participants n=27 Participants	33 participants n=483 Participants	131 participants n=36 Participants
Race/Ethnicity, Customized Missing	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants	1 participants n=36 Participants
Baseline Severity Moderate	108 Participants n=93 Participants	254 Participants n=4 Participants	237 Participants n=27 Participants	235 Participants n=483 Participants	834 Participants n=36 Participants
Baseline Severity Severe	69 Participants n=93 Participants	127 Participants n=4 Participants	133 Participants n=27 Participants	130 Participants n=483 Participants	459 Participants n=36 Participants
Baseline Severity Baseline Severity missing	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.

Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Outcome measures

Measure	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=176 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=369 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=380 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Reporting Pain Freedom at 2 Hours Postdose	39 Participants	29 Participants	88 Participants	88 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.

Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Outcome measures

Measure	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=176 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=369 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=380 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Reporting Pain Relief at 2 Hours Post Dose	120 Participants	78 Participants	205 Participants	205 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.

Outcome measures

Measure	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=176 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=369 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=380 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose	119 Participants	72 Participants	179 Participants	176 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.

Outcome measures

Measure	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=176 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=369 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=380 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose	152 Participants	85 Participants	206 Participants	192 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.

Outcome measures

Measure	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=176 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=369 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=380 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose	196 Participants	113 Participants	258 Participants	260 Participants

SECONDARY outcome

Timeframe: 2 to 24 hours postdose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)

Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.

Outcome measures

Measure	Placebo n=363 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=177 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=365 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=378 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose	26 Participants	25 Participants	63 Participants	62 Participants

SECONDARY outcome

Timeframe: 2 to 24 hours postdose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)

Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.

Outcome measures

Measure	Placebo n=363 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=177 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=365 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=378 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose	23 Participants	20 Participants	54 Participants	55 Participants

SECONDARY outcome

Timeframe: 2 hours postdose

Population: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Pain Freedom and no migraine-associated symptoms at 2 hours postdose.

Outcome measures

Measure	Placebo n=365 Participants Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	MK0974 50 mg n=176 Participants MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=369 Participants MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=380 Participants MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose	36 Participants	24 Participants	78 Participants	78 Participants

Adverse Events

MK0974 50 mg

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

MK0974 150 mg

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

MK0974 300 mg

Serious events: 0 serious events

Other events: 94 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK0974 50 mg n=177 participants at risk MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=381 participants at risk MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=370 participants at risk MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	Placebo n=366 participants at risk Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Injury, poisoning and procedural complications Traumatic Brain Injury	0.00% 0/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.00% 0/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.00% 0/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.27% 1/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Vascular disorders Hypertension	0.00% 0/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.26% 1/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.00% 0/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.00% 0/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".

Other adverse events

Measure	MK0974 50 mg n=177 participants at risk MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack	MK0974 150 mg n=381 participants at risk MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack	MK0974 300 mg n=370 participants at risk MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack	Placebo n=366 participants at risk Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Ear and labyrinth disorders Vertigo	1.7% 3/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.52% 2/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	1.4% 5/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.7% 10/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Gastrointestinal disorders Abdominal Pain Upper	1.1% 2/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	1.0% 4/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.2% 12/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	1.6% 6/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Gastrointestinal disorders Dry Mouth	5.1% 9/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	4.5% 17/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	5.1% 19/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	5.2% 19/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Gastrointestinal disorders Nausea	7.9% 14/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.4% 13/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	5.1% 19/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	5.5% 20/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Gastrointestinal disorders Vomiting	3.4% 6/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.79% 3/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	1.6% 6/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.7% 10/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
General disorders Fatigue	5.1% 9/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.9% 15/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	6.8% 25/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.8% 14/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Nervous system disorders Dizziness	7.3% 13/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.4% 9/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	5.4% 20/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.3% 12/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Nervous system disorders Headache	0.00% 0/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.79% 3/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	0.81% 3/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.2% 8/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Nervous system disorders Paraesthesia	1.7% 3/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	1.3% 5/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.2% 8/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.5% 9/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
Nervous system disorders Somnolence	4.0% 7/177 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.7% 14/381 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	2.7% 10/370 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".	3.0% 11/366 • Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy. Subjective adverse experiences were recorded by the patient in a paper diary. Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: ClinicalTrialDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER