Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-0974-031 | Other Identifier | Merck Protocol Number | |
| 2007_546 | Other Identifier | Telerx ID Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telcagepant 140 mg | Experimental | Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. |
|
| Telcagepant 280 mg | Experimental | Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. |
|
| Control Group 1 | Placebo Comparator | Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. |
|
| Control Group 2 | Placebo Comparator | Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telcagepant 140 mg | Drug | Telcagepant 140 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. | 2 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. | 2 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC. | 2 hours post-dose (up to 6 months) |
| Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20974601 | Derived | Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telcagepant 140 mg | Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. |
| FG001 | Telcagepant 280 mg | Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. |
| FG002 | Placebo | The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
|
| |||||||||||||||||||||
| Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telcagepant 140 mg | Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. | The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours. | Posted | Number | Percentage of participants | 2 hours post-dose for the first migraine attack (up to 6 months) |
|
Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telcagepant 140 mg | Participants who received at least one dose of telcagepant 140 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C525458 | telcagepant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Talcagepant 280 mg | Drug | Telcagepant 280 mg tablets |
|
| Placebo | Drug | Placebo tablets |
|
| 2 hours post-dose (up to 6 months) |
| Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points. | 2 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points. | 2 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | The participant recorded whether nausea was present or absent at each of the predefined time points. | 2 hours post-dose for the first migraine attack (up to 6 months) |
| Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups. | Up to 48 hours post-dose for the first migraine attack (up to 6 months) |
| Number of Participants Discontinuing Study Medication Due to an AE | Participants discontinuing study medication due to an AE were reported for all migraine attacks. | Up to the 4th dose of study medication (up to 6 months) |
| From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) | Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication. | From 2 to 48 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) | TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication. | 2 hours post-dose for the first migraine attack (up to 6 months) |
| Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication. | From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) |
| Lost to Follow-up |
|
| Pregnancy |
|
| Physician Decision |
|
| Progressive disease |
|
| Lack of qualifying migraines |
|
| NOT COMPLETED |
|
|
| Telcagepant 280 mg |
Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. |
| BG002 | Placebo | The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. |
| OG001 | Telcagepant 280 mg | Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. |
| OG002 | Placebo | The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. |
|
|
|
| Primary | Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours. | Posted | Number | Percentage of participants | 2 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Primary | Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC. | The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks. | Posted | Number | Percentage of participants | 2 hours post-dose (up to 6 months) |
|
|
|
|
| Primary | Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC. | The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks. | Posted | Number | Percentage of participants | 2 hours post-dose (up to 6 months) |
|
|
|
|
| Primary | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points. | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours. | Posted | Number | Percentage of participants | 2 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Primary | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points. | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours. | Posted | Number | Percentage of participants | 2 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Primary | Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | The participant recorded whether nausea was present or absent at each of the predefined time points. | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours. | Posted | Number | Percentage of participants | 2 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Primary | Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups. | The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group. | Posted | Number | Participants | Up to 48 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
| Primary | Number of Participants Discontinuing Study Medication Due to an AE | Participants discontinuing study medication due to an AE were reported for all migraine attacks. | The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group. | Posted | Number | Participants | Up to the 4th dose of study medication (up to 6 months) |
|
|
|
| Secondary | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication. | The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question. | Posted | Number | Percentage of participants | From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Secondary | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) | Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication. | The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 48 hrs, or a recurrence question. | Posted | Number | Percentage of participants | From 2 to 48 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Secondary | Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) | TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication. | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours. | Posted | Number | Percentage of participants | 2 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| Secondary | Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication. | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 24 hours. | Posted | Number | Percentage of participants | From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) |
|
|
|
|
| 8 |
| 573 |
| 166 |
| 573 |
| EG001 | Telcagepant 280 mg | Participants who received at least one dose of telcagepant 280 mg. | 8 | 543 | 144 | 543 |
| EG002 | Placebo | Participants who received at least one dose of placebo. | 4 | 561 | 138 | 561 |
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D009422 | Nervous System Diseases |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 2.80 |
| 2-Sided |
| 95 |
| 2.17 |
| 3.61 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 6.18 |
| 2-Sided |
| 95 |
| 3.36 |
| 11.39 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 3.23 |
| 2-Sided |
| 95 |
| 2.41 |
| 4.34 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 1.67 |
| 2-Sided |
| 95 |
| 1.31 |
| 2.14 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 1.61 |
| 2-Sided |
| 95 |
| 1.26 |
| 2.06 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 1.57 |
| 2-Sided |
| 95 |
| 1.21 |
| 2.04 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 3.45 |
| 2-Sided |
| 95 |
| 2.30 |
| 5.19 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 3.37 |
| 2-Sided |
| 95 |
| 2.22 |
| 5.12 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 2.81 |
| 2-Sided |
| 95 |
| 1.97 |
| 4.01 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |
| Regression, Logistic |
Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age. |
| <0.001 |
| Odds Ratio (OR) |
| 3.02 |
| 2-Sided |
| 95 |
| 2.00 |
| 4.56 |
An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison. |
| Superiority or Other |