Trial Outcomes & Findings for Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012) (NCT NCT00443209)
NCT ID: NCT00443209
Last Updated: 2018-10-17
Results Overview
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1068 participants
Primary outcome timeframe
Within 14 days of any dose of study drug (Up to 18.5 months)
Results posted on
2018-10-17
Participant Flow
The trial was considered to have achieved completion as defined by the treatment of 100 participants for 12 months.
Participant milestones
| Measure |
Telcagepant 280 mg/300 mg
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Months 1 to 12 Treatment Period
STARTED
|
712
|
356
|
|
Months 1 to 12 Treatment Period
Treated
|
641
|
313
|
|
Months 1 to 12 Treatment Period
COMPLETED
|
367
|
202
|
|
Months 1 to 12 Treatment Period
NOT COMPLETED
|
345
|
154
|
|
Months 13 to 18 Treatment Period
STARTED
|
186
|
86
|
|
Months 13 to 18 Treatment Period
COMPLETED
|
87
|
39
|
|
Months 13 to 18 Treatment Period
NOT COMPLETED
|
99
|
47
|
Reasons for withdrawal
| Measure |
Telcagepant 280 mg/300 mg
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Months 1 to 12 Treatment Period
Adverse Event
|
22
|
11
|
|
Months 1 to 12 Treatment Period
Protocol Violation
|
14
|
7
|
|
Months 1 to 12 Treatment Period
Lack of Efficacy
|
50
|
11
|
|
Months 1 to 12 Treatment Period
Lack of Qualifying Event
|
1
|
1
|
|
Months 1 to 12 Treatment Period
Lost to Follow-up
|
36
|
15
|
|
Months 1 to 12 Treatment Period
Physician Decision
|
8
|
4
|
|
Months 1 to 12 Treatment Period
Pregnancy
|
3
|
4
|
|
Months 1 to 12 Treatment Period
Trial Terminated
|
43
|
23
|
|
Months 1 to 12 Treatment Period
Withdrawal by Subject
|
95
|
34
|
|
Months 1 to 12 Treatment Period
Missing
|
2
|
1
|
|
Months 1 to 12 Treatment Period
Not Treated
|
71
|
43
|
|
Months 13 to 18 Treatment Period
Adverse Event
|
1
|
0
|
|
Months 13 to 18 Treatment Period
Protocol Violation
|
1
|
0
|
|
Months 13 to 18 Treatment Period
Lack of Efficacy
|
1
|
0
|
|
Months 13 to 18 Treatment Period
Lost to Follow-up
|
2
|
2
|
|
Months 13 to 18 Treatment Period
Trial Terminated
|
87
|
43
|
|
Months 13 to 18 Treatment Period
Withdrawal by Subject
|
7
|
2
|
Baseline Characteristics
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
Baseline characteristics by cohort
| Measure |
Telcagepant 280 mg/300 mg
n=641 Participants
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 Participants
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
Total
n=954 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
41.9 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
42.3 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
502 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
739 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 14 days of any dose of study drug (Up to 18.5 months)Population: The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug.
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.
Outcome measures
| Measure |
Telcagepant 280 mg/300 mg
n=641 Participants
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 Participants
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
|
5.0 Percentage of Participants
|
11.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Within 14 days of any dose of study drug (Up to 18.5 months)Population: The APAT population consisted of all participants who received at least one dose of study drug.
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 product, whether or not considered related to the use of the product. 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 product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.
Outcome measures
| Measure |
Telcagepant 280 mg/300 mg
n=641 Participants
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 Participants
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Percentage of Participants With At Least One Clinical AE
|
58.7 Percentage of Participants
|
63.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Within 14 days of any dose of study drug (Up to 18.5 months)Population: The APAT population consisted of all participants who received at least one dose of study drug.
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 product, whether or not considered related to the use of the product. 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 product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.
Outcome measures
| Measure |
Telcagepant 280 mg/300 mg
n=641 Participants
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 Participants
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Percentage of Participants With At Least One Laboratory AE
|
1.9 Percentage of Participants
|
1.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Within 14 days of any dose of study drug (Up to 18.5 months)Population: The APAT population consisted of all participants who received at least one dose of study drug.
Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (\>=180 mm Hg and 20 mm Hg increase OR \<=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (\>=105 mm Hg and 15 mm Hg increase OR \<=50 mm Hg and 15 mm Hg decrease), Pulse (\>=120 beats per minute \[bpm\] and 15 bpm increase OR \<=50 bpm and 15 bpm decrease), Body Temperature (\>38º C \[oral equivalent\]) and Respiratory Rate (\>25 or increase of 10 OR \<5 or decrease of 10 \[per minute\]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.
Outcome measures
| Measure |
Telcagepant 280 mg/300 mg
n=641 Participants
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 Participants
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Respiratory Rate Increase or Decrease
|
0.8 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Systolic Blood Pressure Increase
|
0.2 Percentage of Participants
|
0.3 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Systolic Blood Pressure Decrease
|
1.4 Percentage of Participants
|
1.3 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Diastolic Blood Pressure Increase
|
0.3 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Diastolic Blood Pressure Decrease
|
1.1 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Pulse Increase
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Pulse Decrease
|
0.6 Percentage of Participants
|
1.6 Percentage of Participants
|
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Body Temperature Increase
|
0.3 Percentage of Participants
|
0.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 2 hours post-dose (Up to 18 months)Population: The Full Analysis Set (FAS) population consisted of all participants who were randomized and reported at least one treated migraine attack with at least one post-treatment efficacy evaluation.
Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.
Outcome measures
| Measure |
Telcagepant 280 mg/300 mg
n=592 Participants
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=294 Participants
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
|
38.9 Percentage of Migraine Attacks
Standard Deviation 29.5
|
47.5 Percentage of Migraine Attacks
Standard Deviation 29.7
|
Adverse Events
Telcagepant 280 mg/300 mg
Serious events: 12 serious events
Other events: 187 other events
Deaths: 0 deaths
Rizatriptan 10 mg
Serious events: 6 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telcagepant 280 mg/300 mg
n=641 participants at risk
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 participants at risk
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.32%
1/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sqamous cell carcinoma
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.32%
1/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.32%
1/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.32%
1/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.16%
1/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.32%
1/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.32%
1/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Telcagepant 280 mg/300 mg
n=641 participants at risk
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
Rizatriptan 10 mg
n=313 participants at risk
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
9.7%
62/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
13.7%
43/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.0%
58/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
6.4%
20/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
2.2%
14/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
5.1%
16/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
4.8%
31/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
10.2%
32/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
17/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
5.1%
16/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.9%
57/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
10.2%
32/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
9.2%
59/641 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.6%
52/313 • Up to 14 days after any dose of study drug (Up to 18.5 months)
The population consisted of all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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.
- Publication restrictions are in place
Restriction type: OTHER