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This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
|
| E2007 | Experimental | During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF) | A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment) | Baseline to Week 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF) | The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with chronic daily headaches as defined by more than 14 headache days per month on average during the three months prior to Screening,
Patients with cluster headaches and other trigeminal autonomic cephalalgias, and other primary headaches (except tension-type headache) and secondary headaches (defined according to the Headache Classification Committee of the IHS 2004),
Patients with a history of being non-responsive to more than two classes of adequately conducted, prophylactic migraine treatments (e.g., beta blockers, calcium channel blockers, tricyclics, MAOIs, valproate (divalproex), topiramate, gabapentin),
Patients who use the following medications as described:
Patients with clinically significant neurological illness, other than migraine, that, in the opinion of the Investigators, may have the potential of altering pain perception or reporting,
Patients with a history of or currently having major psychiatric disorders including schizophrenia, major depressive disorder, or bipolar disorder,
Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV),
Patients with elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >= 1.5 times the upper limit of normal (ULN),
Patients with evidence of significant active hematological disease; white blood cell count cannot be less than or equal to 2500/uL or an absolute neutrophil count less than or equal to 1000/uL,
Patients with clinically significant ECG abnormality, including prolonged QTc (Fridericia correction) defined as >= 450 msec for males and >= 470 msec for females,
Patients with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, and bacterial or viral infections within 30 days prior to Screening or during the Baseline Phase,
Patients with known or suspected history of alcoholism or drug abuse within the previous two years, or a positive finding on urinary drug screening of other than prescribed medications,
Patients who have had severe allergic reactions to multiple drugs,
Patients with any other condition that would make them, in the opinion of the PI, unsuitable for this study,
Patients that have participated in a study involving administration of an investigational compound (including E2007) within one month of Visit 1 (Screening),
Patients with a known or suspected allergy to lactose, excluding lactose intolerance,
Patients who use the following medications for any medical reason during the study: beta-blockers, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, NSAIDs daily, magnesium supplements at high doses (ie, 600 mg/day), riboflavin at high doses (ie, 100 mg/day), corticosteroids, local anesthetics, botuliunum toxin, or herbal preparations such as feverfew or St. John's Wort. Patients who use non-pharmacological prophylactic approaches that were started at least one month prior to Screening may be continued throughout the study.
(revised per Amendment 03)
Patients who fail to complete the migraine diary adequately during the Baseline Phase (ie, patients, who do not have complete diary entries for at least 21 days of the Baseline Phase).
Randomized patients will be both male and female, 18-65 years of age, of any race, with a history of migraine headaches (with or without aura according to the Headache Classification Committee of the International Headache Society (IHS, 2004 guideline) for at least 12 months, with an onset before age 50, experiencing 4-12 migraine attacks per month during both the 3 months prior to Screening and the Baseline Phase. Patients' Body Mass Index (BMI) should be between 19 to 40 kg/m2 inclusive at Screening.
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| Name | Affiliation | Role |
|---|---|---|
| Julia Young, M.D., Ph.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Oceanside | California | 92056 | United States | ||
| Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| FG001 | E2007 | During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF) | The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error. | ITT Population | Posted | Mean | Standard Error | Hours | Baseline to Week 19 |
|
From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23.
Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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|
| Baseline to Week 19 |
| Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF) | The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule. | Baseline to Week 19 |
| Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF) | Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule. | Baseline to Week 19 |
| Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase | A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. | Baseline, Week 11 to Week 19 |
| Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF) | The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error. | Baseline to Week 19 |
| Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF) | A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error. | Baseline to Week 19 |
| Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF) | The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from "very much improved" with a score of 1 to "very much worse" with a score of 7. A responder is defined as being "very much improved" or "much improved". The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment) | Baseline to Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful. | Baseline, Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation. | Baseline, Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation. | Baseline, Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation. | Baseline, Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation. | Baseline, Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation. | Baseline, Week 23 |
| Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation. | Baseline, Week 23 |
| Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF) | Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule. | Week 5 to Week 19 |
| Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF) | A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants. | Week 5 to Week 19 |
| Santa Monica |
| California |
| 90404 |
| United States |
| Investigational Site | Tampa | Florida | 33606 | United States |
| Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Investigational Site | Chicago | Illinois | 60614 | United States |
| Investigational Site | Springfield | Missouri | 65807 | United States |
| Elkind Headache Center | Mount Vernon | New York | 10550 | United States |
| Investigational Site | Greensboro | North Carolina | 27401 | United States |
| Investigational Site | Houston | Texas | 77004 | United States |
| Investigator or Sponsor Request |
|
| Withdrawal by Subject |
|
| Other |
|
| E2007 |
During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Male and female (either of non-childbearing potential, childbearing potential and practicing a medically acceptable method of contraception, surgically sterile, or postmenopausal for greater or equal to 1 year) subjects with a history of migraine experiencing 4 to 12 migraine attacks per month during both the 3 months prior to Screening and the Baseline Phase. | Count of Participants | Participants |
|
| OG001 | E2007 (24 Hour Rule) | During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| OG002 | Placebo (48 Hour Rule) | During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
| OG003 | E2007 (48 Hour Rule) | During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). |
|
|
| Secondary | Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF) | The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule. | ITT Population | Posted | Mean | Standard Error | Units on a Scale | Baseline to Week 19 |
|
|
|
| Secondary | Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF) | Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule. | ITT Population | Posted | Mean | Standard Error | Migraine attack | Baseline to Week 19 |
|
|
|
| Secondary | Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase | A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. | ITT Population | Posted | Mean | Standard Error | Migraine period | Baseline, Week 11 to Week 19 |
|
|
|
| Primary | Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF) | A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment) | The efficacy analysis was performed on the Intention to treat (ITT) Population, which was defined as all randomized subjects who received at least 1 dose of double-blind study medication, and had baseline and postbaseline migraine assessments in at least 1 phase. | Posted | Mean | Standard Error | Migraine period | Baseline to Week 19 |
|
|
|
| Secondary | Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF) | The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error. | ITT Population | Posted | Mean | Standard Error | Days | Baseline to Week 19 |
|
|
|
| Secondary | Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF) | A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error. | ITT Population | Posted | Mean | Standard Error | Days | Baseline to Week 19 |
|
|
|
| Secondary | Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF) | The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from "very much improved" with a score of 1 to "very much worse" with a score of 7. A responder is defined as being "very much improved" or "much improved". The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment) | ITT Population | Posted | Number | Participants | Baseline to Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | Days | Baseline, Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | Days | Baseline, Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | Days | Baseline, Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | Days | Baseline, Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | Days | Baseline, Week 23 |
|
|
|
| Secondary | Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School | The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation. | ITT Population. Only patients with non-missing baseline data are summarized. | Posted | Mean | Standard Deviation | Days | Baseline, Week 23 |
|
|
|
| Secondary | Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF) | Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule. | ITT Population | Posted | Number | Percentage of Participants | Week 5 to Week 19 |
|
|
|
| Secondary | Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF) | A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants. | ITT Population | Posted | Number | Percentage of Participants | Week 5 to Week 19 |
|
|
|
| 1 |
| 104 |
| 75 |
| 104 |
| EG001 | E2007 | During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). | 1 | 102 | 74 | 102 |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| ?Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA | Systematic Assessment |
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| Malaise | General disorders | MedDRA | Systematic Assessment |
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| Thirst | General disorders | MedDRA | Systematic Assessment |
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| Chills | General disorders | MedDRA | Systematic Assessment |
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| Exercise tolerance decreased | General disorders | MedDRA | Systematic Assessment |
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| Granuloma | General disorders | MedDRA | Systematic Assessment |
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| Injected limb mobility decreased | General disorders | MedDRA | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Pre-existing condition improved | General disorders | MedDRA | Systematic Assessment |
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| Sluggishness | General disorders | MedDRA | Systematic Assessment |
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| Swelling | General disorders | MedDRA | Systematic Assessment |
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| Tenderness | General disorders | MedDRA | Systematic Assessment |
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| Liver tenderness | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
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| Multiple allergies | Immune system disorders | MedDRA | Systematic Assessment |
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| ?Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis viral | Infections and infestations | MedDRA | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Dental caries | Infections and infestations | MedDRA | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Kidney infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Vaginal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| ?Back injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Human bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Bacteria urine | Investigations | MedDRA | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA | Systematic Assessment |
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| Crystal urine present | Investigations | MedDRA | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA | Systematic Assessment |
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| Blood potassium abnormal | Investigations | MedDRA | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
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| Cardiac murmur functional | Investigations | MedDRA | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
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| Gastric pH decreased | Investigations | MedDRA | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA | Systematic Assessment |
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| Haematology test abnormal | Investigations | MedDRA | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
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| Mean cell volume decreased | Investigations | MedDRA | Systematic Assessment |
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| Platelet count increased | Investigations | MedDRA | Systematic Assessment |
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| Urinary sediment present | Investigations | MedDRA | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA | Systematic Assessment |
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| Weight increased | Investigations | MedDRA | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Anosmia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dysaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
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| ?Mental impairment | Nervous system disorders | MedDRA | Systematic Assessment |
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| Muscle spasticity | Nervous system disorders | MedDRA | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Parosmia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Thinking abnormal | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Genital rash | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Premenstrual syndrome | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| ?Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Onychorrhexis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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Not provided
Not provided
| Worsened |
|