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Trial record 10 of 179 for:    Migraine AND migraine with or without aura

Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (SPARTAN)

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ClinicalTrials.gov Identifier: NCT02605174
Recruitment Status : Completed
First Posted : November 16, 2015
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine With or Without Aura
Interventions Drug: Lasmiditan 50 mg
Drug: Lasmiditan 100 mg
Drug: Lasmiditan 200 mg
Drug: Placebo
Enrollment 3005
Recruitment Details  
Pre-assignment Details Participants were randomly assigned to 1 of 7 sequences and received lasmiditan 50 mg (L50 mg), lasmiditan 100 mg (L100 mg) or lasmiditan 200 mg (L200 mg) or placebo (P) for the first dose and the second dose, if needed for rescue or recurrence of migraine.
Arm/Group Title Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmitidan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmitidan 200 mg/Placebo Placebo/Placebo
Hide Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, daily for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Period Title: Overall Study
Started 501 249 502 252 501 249 751
Received at Least 1 Dose of Study Drug 429 225 423 212 434 215 645
Received Optional 2nd Dose 206 96 177 83 144 74 361
Completed [1] 437 226 426 216 448 217 662
Not Completed 64 23 76 36 53 32 89
Reason Not Completed
Adverse Event             0             0             1             0             4             0             0
Lost to Follow-up             20             7             27             10             20             10             29
Protocol Violation             10             4             14             6             7             7             12
Pregnancy             1             0             0             2             0             0             0
Withdrawal by Subject             9             6             14             11             6             4             15
Physician Decision             2             0             0             0             0             0             3
Randomization Failure             22             6             20             7             16             11             30
[1]
One site was burned down and several participants have incomplete data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo Total
Hide Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Total of all reporting groups
Overall Number of Baseline Participants 654 635 649 645 2583
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 654 participants 635 participants 649 participants 645 participants 2583 participants
42.8  (13.20) 43.4  (12.59) 41.8  (12.40) 42.6  (12.90) 42.7  (12.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 654 participants 635 participants 649 participants 645 participants 2583 participants
Female 554 539 536 545 2174
Male 100 96 113 100 409
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 654 participants 635 participants 649 participants 645 participants 2583 participants
American Indian or Alaska Native 3 2 2 5 12
Asian 5 6 7 3 21
Black or African American 106 104 106 110 426
Native Hawaiian or other Pacific Islander 2 1 2 2 7
White 524 509 522 516 2071
Other 6 8 4 4 22
Multiple 8 5 5 5 23
Missing 0 0 1 0 1
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 654 participants 635 participants 649 participants 645 participants 2583 participants
Hispanic or Latino 135 137 136 124 532
Not Hispanic or Latino 515 493 511 518 2037
Not Reported 3 3 0 3 9
Unknown 1 2 1 0 4
Missing 0 0 1 0 1
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 654 participants 635 participants 649 participants 645 participants 2583 participants
Germany 77 79 77 77 310
United Kingdom 48 48 47 48 191
United States 625 627 626 626 2504
[1]
Measure Analysis Population Description: Participants in each region are those who were randomized to each arm.
1.Primary Outcome
Title Percentage of Participants Headache Pain Free at 2 Hours Post Dose
Hide Description The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 556 532 528 539
Measure Type: Number
Unit of Measure: percentage of participants
28.6 31.4 38.8 21.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1.1 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.3 to 2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.8 to 3.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
Hide Description The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable MBS data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 512 500 483 514
Measure Type: Number
Unit of Measure: percentage of participants
40.8 44.2 48.7 33.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.1 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.2 to 2.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.4 to 2.4
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Percentage of Participants With Headache Relief
Hide Description The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable headache relief data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 575
Measure Type: Number
Unit of Measure: percentage of participants
59.0 64.8 65.0 47.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.3 to 2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.7 to 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.8 to 3.1
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Number of Participants With Headache Recurrence
Hide Description The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)
Time Frame From 2 Hours Post Dose Up to 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable headache recurrence data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 159 167 205 115
Measure Type: Count of Participants
Unit of Measure: Participants
38 44 52 26
5.Other Pre-specified Outcome
Title Percentage of Participants Use of Rescue Medication
Hide Description The percentage of participants who used rescue medication.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 576
Measure Type: Number
Unit of Measure: percentage of participants
31.9 26.4 18.9 40.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.5 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.4 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.3 to 0.4
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Percentage of Participants Use of Rescue Medication
Hide Description The percentage of participants who used rescue medication.
Time Frame From 2 Hours Post Dose Up to 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 576
Measure Type: Number
Unit of Measure: percentage of participants
8.9 6.3 7.4 8.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.7 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.5 to 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.456
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.6 to 1.3
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Percentage of Participants Use of Rescue Medication
Hide Description The percentage of participants who used rescue medication.
Time Frame From 24 Post Dose Up to 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 576
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0 0.0
8.Other Pre-specified Outcome
Title Percentage of Participants Nausea Free
Hide Description The percentage of participant without nausea.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable nausea free data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 576
Measure Type: Number
Unit of Measure: percentage of participants
68.7 71.8 70.4 70.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.522
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.622
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.8 to 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.8 to 1.3
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Percentage of Participants With Phonophobia Free
Hide Description The percentage of participants without phonophobia.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable phonophobia free data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 576
Measure Type: Number
Unit of Measure: percentage of participants
61.2 64.8 65.3 53.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.1 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.3 to 2.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.3 to 2.1
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Percentage of Participants With Photophobia Free
Hide Description The percentage of participants without photophobia.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 598 571 565 576
Measure Type: Number
Unit of Measure: percentage of participants
51.2 56.4 58.2 43.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.1 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.3 to 2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
1.4 to 2.3
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Percentage of Participants With Resource Utilization
Hide Description Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study
Time Frame 6 Months Prior to Enrolling in Study to End of Study (Up to 11 Weeks) Within 7 Days of Treating a Single Migraine Attack
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had received at least one dose of study drug and had evaluable resource utilization data.
Arm/Group Title Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 429 225 423 212 434 215 645
Measure Type: Number
Unit of Measure: percentage of participants
6 months prior to enrolling 4.7 2.2 2.8 2.4 3.2 3.3 2.9
During time of study 0.5 0 0.5 0 0.9 0.5 0.6
12.Other Pre-specified Outcome
Title Number of Participants With Treatment Emergent Events
Hide Description Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
Time Frame From Baseline Up to End of Study (Up to 11 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.
Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
Hide Arm/Group Description:
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Overall Number of Participants Analyzed 654 635 649 645
Measure Type: Number
Unit of Measure: participants
167 230 253 75
Time Frame From Baseline Up to End of Study (Up to 11 Weeks)
Adverse Event Reporting Description The safety population includes all participants who received at least one dose of study drug and the optional second dose.
 
Arm/Group Title Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
Hide Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 100 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 200 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered within 24 hours for rescue or recurrence of migraine.
All-Cause Mortality
Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/429 (0.00%)      0/225 (0.00%)      0/423 (0.00%)      0/212 (0.00%)      0/435 (0.00%)      0/217 (0.00%)      0/646 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/429 (0.23%)      0/225 (0.00%)      1/423 (0.24%)      1/212 (0.47%)      3/435 (0.69%)      0/217 (0.00%)      2/646 (0.31%)    
Gastrointestinal disorders               
Intestinal obstruction  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Hepatobiliary disorders               
Cholelithiasis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Pituitary tumour benign  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Nervous system disorders               
Presyncope  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Psychiatric disorders               
Somatisation disorder  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Surgical and medical procedures               
Surgery  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Vascular disorders               
Deep vein thrombosis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Hypotension  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   118/429 (27.51%)      61/225 (27.11%)      149/423 (35.22%)      94/212 (44.34%)      177/435 (40.69%)      87/217 (40.09%)      80/646 (12.38%)    
Cardiac disorders               
Palpitations  1  3/429 (0.70%)  4 0/225 (0.00%)  0 1/423 (0.24%)  1 1/212 (0.47%)  1 1/435 (0.23%)  1 1/217 (0.46%)  2 1/646 (0.15%)  1
Tachycardia  1  0/429 (0.00%)  0 1/225 (0.44%)  1 2/423 (0.47%)  2 0/212 (0.00%)  0 1/435 (0.23%)  1 1/217 (0.46%)  1 0/646 (0.00%)  0
Ear and labyrinth disorders               
Ear discomfort  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Motion sickness  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Tinnitus  1  1/429 (0.23%)  1 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 1/646 (0.15%)  1
Vertigo  1  1/429 (0.23%)  1 1/225 (0.44%)  1 3/423 (0.71%)  3 2/212 (0.94%)  3 3/435 (0.69%)  3 2/217 (0.92%)  2 1/646 (0.15%)  1
Endocrine disorders               
Hyperthyroidism  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Eye disorders               
Blepharospasm  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Chromatopsia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Keratitis  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Mydriasis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Ocular hyperaemia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Photopsia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Strabismus  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Vision blurred  1  1/429 (0.23%)  1 0/225 (0.00%)  0 1/423 (0.24%)  1 2/212 (0.94%)  2 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Visual acuity reduced  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Visual impairment  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 1/212 (0.47%)  1 2/435 (0.46%)  2 1/217 (0.46%)  1 0/646 (0.00%)  0
Vitreous floaters  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Gastrointestinal disorders               
Abdominal discomfort  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Abdominal pain  1  0/429 (0.00%)  0 1/225 (0.44%)  1 1/423 (0.24%)  1 2/212 (0.94%)  2 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Abdominal pain upper  1  2/429 (0.47%)  2 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 1/217 (0.46%)  1 0/646 (0.00%)  0
Diarrhoea  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  2 0/212 (0.00%)  0 1/435 (0.23%)  1 1/217 (0.46%)  1 1/646 (0.15%)  2
Dry mouth  1  2/429 (0.47%)  3 0/225 (0.00%)  0 1/423 (0.24%)  1 1/212 (0.47%)  1 2/435 (0.46%)  2 1/217 (0.46%)  1 2/646 (0.31%)  2
Dyspepsia  1  1/429 (0.23%)  1 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Hypoaesthesia oral  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Lip dry  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Nausea  1  12/429 (2.80%)  12 6/225 (2.67%)  6 13/423 (3.07%)  13 9/212 (4.25%)  9 14/435 (3.22%)  14 4/217 (1.84%)  4 9/646 (1.39%)  9
Paraesthesia oral  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 3/435 (0.69%)  3 0/217 (0.00%)  0 1/646 (0.15%)  1
Retching  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Toothache  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Vomiting  1  1/429 (0.23%)  2 4/225 (1.78%)  4 2/423 (0.47%)  2 2/212 (0.94%)  2 3/435 (0.69%)  3 3/217 (1.38%)  3 3/646 (0.46%)  3
General disorders               
Asthenia  1  2/429 (0.47%)  2 2/225 (0.89%)  2 2/423 (0.47%)  2 4/212 (1.89%)  4 8/435 (1.84%)  8 4/217 (1.84%)  4 1/646 (0.15%)  1
Chest discomfort  1  0/429 (0.00%)  0 2/225 (0.89%)  2 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 2/217 (0.92%)  2 2/646 (0.31%)  2
Chills  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 2/646 (0.31%)  2
Face oedema  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Fatigue  1  13/429 (3.03%)  13 7/225 (3.11%)  7 13/423 (3.07%)  13 15/212 (7.08%)  15 21/435 (4.83%)  21 12/217 (5.53%)  12 6/646 (0.93%)  6
Feeling abnormal  1  0/429 (0.00%)  0 2/225 (0.89%)  2 3/423 (0.71%)  3 1/212 (0.47%)  1 4/435 (0.92%)  4 1/217 (0.46%)  1 1/646 (0.15%)  1
Feeling cold  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 1/646 (0.15%)  1
Feeling hot  1  0/429 (0.00%)  0 0/225 (0.00%)  0 2/423 (0.47%)  2 0/212 (0.00%)  0 3/435 (0.69%)  3 0/217 (0.00%)  0 0/646 (0.00%)  0
Feeling jittery  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 2/435 (0.46%)  2 2/217 (0.92%)  2 0/646 (0.00%)  0
Gait disturbance  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 2/435 (0.46%)  2 1/217 (0.46%)  1 0/646 (0.00%)  0
Malaise  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Mass  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Non-cardiac chest pain  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 2/435 (0.46%)  2 0/217 (0.00%)  0 0/646 (0.00%)  0
Peripheral swelling  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Pyrexia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Sense of oppression  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Thirst  1  0/429 (0.00%)  0 1/225 (0.44%)  1 1/423 (0.24%)  2 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Infections and infestations               
Bronchitis  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Gastroenteritis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Hordeolum  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Influenza  1  2/429 (0.47%)  2 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Laryngitis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Nasopharyngitis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 3/646 (0.46%)  3
Rhinitis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Sinusitis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 1/212 (0.47%)  1 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Upper respiratory tract infection  1  3/429 (0.70%)  3 1/225 (0.44%)  1 2/423 (0.47%)  2 2/212 (0.94%)  2 3/435 (0.69%)  3 2/217 (0.92%)  2 3/646 (0.46%)  3
Urinary tract infection  1  0/429 (0.00%)  0 1/225 (0.44%)  1 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Viral upper respiratory tract infection  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Injury, poisoning and procedural complications               
Arthropod sting  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Contusion  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Ligament sprain  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Skin abrasion  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Tendon injury  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Investigations               
Blood pressure decreased  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Blood pressure increased  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Heart rate increased  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 1/212 (0.47%)  1 1/435 (0.23%)  1 0/217 (0.00%)  0 1/646 (0.15%)  1
Pulse pressure increased  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Metabolism and nutrition disorders               
Decreased appetite  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 2/646 (0.31%)  2
Back pain  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 2/435 (0.46%)  2 1/217 (0.46%)  1 1/646 (0.15%)  1
Muscle spasms  1  1/429 (0.23%)  1 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Muscle twitching  1  0/429 (0.00%)  0 0/225 (0.00%)  0 3/423 (0.71%)  3 0/212 (0.00%)  0 2/435 (0.46%)  2 2/217 (0.92%)  2 1/646 (0.15%)  1
Muscular weakness  1  6/429 (1.40%)  6 1/225 (0.44%)  1 4/423 (0.95%)  4 4/212 (1.89%)  4 7/435 (1.61%)  7 2/217 (0.92%)  2 0/646 (0.00%)  0
Musculoskeletal chest pain  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Musculoskeletal pain  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Musculoskeletal stiffness  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 1/646 (0.15%)  2
Myalgia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Neck pain  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Pain in extremity  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Nervous system disorders               
Aphasia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Ataxia  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 2/435 (0.46%)  2 0/217 (0.00%)  0 0/646 (0.00%)  0
Aura  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Balance disorder  1  1/429 (0.23%)  1 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 2/435 (0.46%)  2 2/217 (0.92%)  2 0/646 (0.00%)  0
Clumsiness  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Cognitive disorder  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 2/435 (0.46%)  2 0/217 (0.00%)  0 0/646 (0.00%)  0
Coordination abnormal  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 2/212 (0.94%)  2 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Disturbance in attention  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Dizziness  1  39/429 (9.09%)  42 18/225 (8.00%)  19 77/423 (18.20%)  84 45/212 (21.23%)  45 89/435 (20.46%)  94 33/217 (15.21%)  33 16/646 (2.48%)  17
Dysaesthesia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Dysarthria  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 2/212 (0.94%)  2 2/435 (0.46%)  2 1/217 (0.46%)  1 0/646 (0.00%)  0
Dysgeusia  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 2/646 (0.31%)  2
Facial spasm  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Formication  1  0/429 (0.00%)  0 0/225 (0.00%)  0 2/423 (0.47%)  3 2/212 (0.94%)  2 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Head discomfort  1  1/429 (0.23%)  1 1/225 (0.44%)  1 1/423 (0.24%)  1 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Headache  1  2/429 (0.47%)  2 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 3/435 (0.69%)  3 0/217 (0.00%)  0 1/646 (0.15%)  1
Hypoaesthesia  1  2/429 (0.47%)  2 0/225 (0.00%)  0 5/423 (1.18%)  6 5/212 (2.36%)  5 10/435 (2.30%)  10 0/217 (0.00%)  0 2/646 (0.31%)  2
Lethargy  1  7/429 (1.63%)  8 2/225 (0.89%)  2 4/423 (0.95%)  4 4/212 (1.89%)  4 7/435 (1.61%)  7 7/217 (3.23%)  7 1/646 (0.15%)  1
Migraine  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Myoclonus  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Paraesthesia  1  11/429 (2.56%)  13 7/225 (3.11%)  7 21/423 (4.96%)  22 17/212 (8.02%)  17 30/435 (6.90%)  34 13/217 (5.99%)  14 6/646 (0.93%)  6
Presyncope  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Psychomotor hyperactivity  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Sedation  1  1/429 (0.23%)  1 0/225 (0.00%)  0 2/423 (0.47%)  2 2/212 (0.94%)  2 2/435 (0.46%)  2 2/217 (0.92%)  2 0/646 (0.00%)  0
Sensory disturbance  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 3/212 (1.42%)  3 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Somnolence  1  24/429 (5.59%)  25 11/225 (4.89%)  11 21/423 (4.96%)  21 10/212 (4.72%)  10 34/435 (7.82%)  36 12/217 (5.53%)  12 13/646 (2.01%)  13
Stupor  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Syncope  1  1/429 (0.23%)  2 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Tremor  1  0/429 (0.00%)  0 1/225 (0.44%)  1 2/423 (0.47%)  2 0/212 (0.00%)  0 4/435 (0.92%)  4 2/217 (0.92%)  2 0/646 (0.00%)  0
Vertigo cns origin  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Psychiatric disorders               
Abnormal dreams  1  2/429 (0.47%)  3 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Adjustment disorder  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Adjustment disorder with anxiety  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Anxiety  1  2/429 (0.47%)  2 1/225 (0.44%)  1 6/423 (1.42%)  6 0/212 (0.00%)  0 3/435 (0.69%)  3 1/217 (0.46%)  1 0/646 (0.00%)  0
Burnout syndrome  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Confusional state  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Delirium  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Depersonalisation  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Depressed mood  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Disorientation  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 2/217 (0.92%)  2 1/646 (0.15%)  1
Euphoric mood  1  2/429 (0.47%)  2 0/225 (0.00%)  0 5/423 (1.18%)  5 0/212 (0.00%)  0 2/435 (0.46%)  2 1/217 (0.46%)  1 0/646 (0.00%)  0
Hallucination  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Hallucination, visual  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Hypervigilance  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Insomnia  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 3/435 (0.69%)  3 0/217 (0.00%)  0 0/646 (0.00%)  0
Mental disorder  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Mental status changes  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Mood swings  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Nightmare  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Panic attack  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 1/217 (0.46%)  1 0/646 (0.00%)  0
Panic reaction  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Restlessness  1  0/429 (0.00%)  0 2/225 (0.89%)  2 2/423 (0.47%)  2 3/212 (1.42%)  3 3/435 (0.69%)  3 0/217 (0.00%)  0 0/646 (0.00%)  0
Sleep disorder  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Sleep terror  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Suicidal ideation  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Renal and urinary disorders               
Urinary incontinence  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Reproductive system and breast disorders               
Metrorrhagia  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 2/435 (0.46%)  2 0/217 (0.00%)  0 0/646 (0.00%)  0
Ovarian cyst  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Postmenopausal haemorrhage  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Chronic obstructive pulmonary disease  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Cough  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Dyspnoea  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Epistaxis  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Nasal congestion  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Nasal odour  1  0/429 (0.00%)  0 1/225 (0.44%)  1 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Oropharyngeal pain  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Paranasal sinus discomfort  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Respiratory tract congestion  1  1/429 (0.23%)  1 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Sinus congestion  1  0/429 (0.00%)  0 0/225 (0.00%)  0 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Throat tightness  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Skin and subcutaneous tissue disorders               
Hyperhidrosis  1  0/429 (0.00%)  0 2/225 (0.89%)  2 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Pruritus  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
Pruritus generalised  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 0/646 (0.00%)  0
Vascular disorders               
Circulatory collapse  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 0/212 (0.00%)  0 1/435 (0.23%)  1 0/217 (0.00%)  0 0/646 (0.00%)  0
Flushing  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 1/435 (0.23%)  1 1/217 (0.46%)  1 2/646 (0.31%)  3
Hot flush  1  2/429 (0.47%)  2 2/225 (0.89%)  2 1/423 (0.24%)  1 0/212 (0.00%)  0 0/435 (0.00%)  0 0/217 (0.00%)  0 3/646 (0.46%)  3
Hypertension  1  0/429 (0.00%)  0 0/225 (0.00%)  0 0/423 (0.00%)  0 1/212 (0.47%)  1 0/435 (0.00%)  0 0/217 (0.00%)  0 1/646 (0.15%)  1
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02605174     History of Changes
Other Study ID Numbers: 16889
H8H-CD-LAHK ( Other Identifier: Eli Lilly and Company )
2015-005689-40 ( EudraCT Number )
COL MIG-302 ( Other Identifier: Colucid )
First Submitted: November 11, 2015
First Posted: November 16, 2015
Results First Submitted: June 28, 2018
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018