Trial Outcomes & Findings for An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (NCT NCT02565186)

NCT ID: NCT02565186

Last Updated: 2020-08-25

Results Overview

An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2171 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2020-08-25

Participant Flow

Participant milestones

Measure	Lasmiditan 100mg Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Overall Study STARTED	1046	1125
Overall Study Received at Least One Dose of Study Drug	991	1039
Overall Study COMPLETED	466	504
Overall Study NOT COMPLETED	580	621

Reasons for withdrawal

Measure	Lasmiditan 100mg Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Overall Study Adverse Event	113	148
Overall Study Lost to Follow-up	102	93
Overall Study Non-Compliance	57	55
Overall Study Withdrawal by Subject	229	214
Overall Study Physician Decision	18	16
Overall Study Sponsor Request	5	9
Overall Study Missing	1	0
Overall Study Did Not Receive Study Drug	55	86

Baseline Characteristics

All randomized participants with available gender data.

Baseline characteristics by cohort

Measure	Lasmiditan 100mg n=1046 Participants Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=1125 Participants Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Total n=2171 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 12.25 • n=1046 Participants	43.4 years STANDARD_DEVIATION 12.33 • n=1125 Participants	43.0 years STANDARD_DEVIATION 12.30 • n=2171 Participants
Sex: Female, Male Female	882 Participants n=1046 Participants • All randomized participants with available gender data.	957 Participants n=1123 Participants • All randomized participants with available gender data.	1839 Participants n=2169 Participants • All randomized participants with available gender data.
Sex: Female, Male Male	164 Participants n=1046 Participants • All randomized participants with available gender data.	166 Participants n=1123 Participants • All randomized participants with available gender data.	330 Participants n=2169 Participants • All randomized participants with available gender data.
Ethnicity (NIH/OMB) Hispanic or Latino	208 Participants n=1046 Participants	240 Participants n=1125 Participants	448 Participants n=2171 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	833 Participants n=1046 Participants	880 Participants n=1125 Participants	1713 Participants n=2171 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=1046 Participants	5 Participants n=1125 Participants	10 Participants n=2171 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=1046 Participants	11 Participants n=1125 Participants	15 Participants n=2171 Participants
Race (NIH/OMB) Asian	7 Participants n=1046 Participants	6 Participants n=1125 Participants	13 Participants n=2171 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=1046 Participants	6 Participants n=1125 Participants	10 Participants n=2171 Participants
Race (NIH/OMB) Black or African American	203 Participants n=1046 Participants	194 Participants n=1125 Participants	397 Participants n=2171 Participants
Race (NIH/OMB) White	805 Participants n=1046 Participants	884 Participants n=1125 Participants	1689 Participants n=2171 Participants
Race (NIH/OMB) More than one race	11 Participants n=1046 Participants	14 Participants n=1125 Participants	25 Participants n=2171 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=1046 Participants	10 Participants n=1125 Participants	22 Participants n=2171 Participants
Region of Enrollment United States	1041 Participants n=1046 Participants	1065 Participants n=1125 Participants	2106 Participants n=2171 Participants
Region of Enrollment United Kingdom	5 Participants n=1046 Participants	38 Participants n=1125 Participants	43 Participants n=2171 Participants
Region of Enrollment Germany	0 Participants n=1046 Participants	22 Participants n=1125 Participants	22 Participants n=2171 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: All randomized participants who received at least one dose of study drug.

An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Outcome measures

Measure	Lasmiditan 100mg n=991 Participants Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=1039 Participants Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Number of Participants With at Least 1 Treatment Emergent Adverse Event	447 Participants	545 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset.

Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).

Outcome measures

Measure	Lasmiditan 100mg n=8837 Migraine Attacks Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=8479 Migraine Attacks Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose	26.7 Percentage of PF Migraine Attacks	32.2 Percentage of PF Migraine Attacks

SECONDARY outcome

Timeframe: Up to 12 months

Population: All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset.

MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.

Outcome measures

Measure	Lasmiditan 100mg n=8045 Migraine Attacks Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=7529 Migraine Attacks Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose	37.2 Percentage of MBS-Free Migraine Attacks	40.8 Percentage of MBS-Free Migraine Attacks

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Population: All randomized participants who received at least one dose of study drug.

Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.

Outcome measures

Measure	Lasmiditan 100mg n=991 Participants Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=1039 Participants Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Percentage of Participants With Medical Resource Utilization Visit to cardiologist	0.6 Percentage of Participants	0.6 Percentage of Participants
Percentage of Participants With Medical Resource Utilization Visit to primary care	0.8 Percentage of Participants	0.9 Percentage of Participants
Percentage of Participants With Medical Resource Utilization Visit to Other providers	0.1 Percentage of Participants	0.2 Percentage of Participants
Percentage of Participants With Medical Resource Utilization Hospitalized	0.5 Percentage of Participants	0.2 Percentage of Participants
Percentage of Participants With Medical Resource Utilization Procedures performed	0.8 Percentage of Participants	0.6 Percentage of Participants
Percentage of Participants With Medical Resource Utilization ER visits or visits to Physicians Office	2.6 Percentage of Participants	2.6 Percentage of Participants

Adverse Events

Lasmiditan 100mg

Serious events: 29 serious events

Other events: 446 other events

Deaths: 0 deaths

Lasmiditan 200mg

Serious events: 36 serious events

Other events: 543 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lasmiditan 100mg n=991 participants at risk Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=1039 participants at risk Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Cardiac disorders Angina pectoris	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial flutter	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bradycardia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus node dysfunction	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Stress cardiomyopathy	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hiatus hernia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess limb	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis perforated	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Carbuncle	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Coccidioidomycosis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Diverticulitis	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sepsis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Subcutaneous abscess	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Femur fracture	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Head injury	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Suture rupture	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer recurrent	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Relapsing-remitting multiple sclerosis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Seizure	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.36% 3/845 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/845 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Drug abuse	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mental status changes	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Schizoaffective disorder bipolar type	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicide attempt	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Endometriosis	0.00% 0/845 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/845 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/845 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertensive urgency	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Measure	Lasmiditan 100mg n=991 participants at risk Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Lasmiditan 200mg n=1039 participants at risk Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Nervous system disorders Balance disorder	0.71% 7/991 • Number of events 21 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 19/1039 • Number of events 31 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ataxia	0.30% 3/991 • Number of events 11 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.67% 7/1039 • Number of events 31 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aura	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.12% 1/845 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/887 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Akathisia	0.20% 2/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 24 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Altered state of consciousness	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aphasia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bundle branch block left	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Palpitations	0.30% 3/991 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Diplacusis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Ear discomfort	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Ear pain	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Hypoacusis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.40% 4/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	1.0% 10/991 • Number of events 15 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.3% 24/1039 • Number of events 53 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Altered visual depth perception	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Blindness transient	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Conjunctivitis allergic	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Dyschromatopsia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye disorder	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Iritis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Metamorphopsia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Miosis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Papilloedema	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Photophobia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Photopsia	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Strabismus	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vision blurred	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Visual impairment	0.30% 3/991 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.77% 8/1039 • Number of events 23 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vitreous floaters	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal hernia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dental caries	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	1.0% 10/991 • Number of events 10 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 12 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Epigastric discomfort	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Food poisoning	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Frequent bowel movements	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hiatus hernia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hypoaesthesia oral	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Irritable bowel syndrome	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	3.9% 39/991 • Number of events 47 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 55/1039 • Number of events 81 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oral pain	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Paraesthesia oral	0.40% 4/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Retching	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Swollen tongue	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Tooth disorder	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Toothache	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	1.7% 17/991 • Number of events 18 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 11/1039 • Number of events 12 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Asthenia	1.5% 15/991 • Number of events 38 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.3% 24/1039 • Number of events 48 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest discomfort	0.30% 3/991 • Number of events 64 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Discomfort	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Facial pain	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	4.7% 47/991 • Number of events 90 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 64/1039 • Number of events 159 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling abnormal	0.71% 7/991 • Number of events 11 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.77% 8/1039 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling cold	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling drunk	0.20% 2/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling hot	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling jittery	0.71% 7/991 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 11 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling of relaxation	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Gait disturbance	0.20% 2/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Hunger	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Influenza like illness	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site erythema	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site swelling	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Malaise	0.30% 3/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Swelling face	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Sphincter of oddi dysfunction	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Seasonal allergy	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Acute sinusitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Atypical pneumonia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bacterial vaginosis	0.00% 0/845 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Body tinea	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Fungal skin infection	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Furuncle	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gingivitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes zoster	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Labyrinthitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lyme disease	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	0.40% 4/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.87% 9/1039 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Otitis externa	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Otitis media acute	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngitis streptococcal	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Rhinitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	0.40% 4/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.77% 8/1039 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tooth abscess	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	1.0% 10/991 • Number of events 10 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection bacterial	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.50% 5/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Viral infection	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Animal bite	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod bite	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.20% 2/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Eye injury	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.40% 4/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.12% 1/845 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/887 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Muscle strain	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood glucose increased	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood phosphorus decreased	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood pressure decreased	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood pressure diastolic increased	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood pressure increased	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood triglycerides increased	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Electrocardiogram t wave biphasic	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Haematocrit decreased	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Heart rate decreased	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Heart rate increased	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Heart rate irregular	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Hepatic enzyme increased	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Norovirus test positive	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Urine analysis abnormal	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight increased	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cells urine positive	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Obesity	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Vitamin d deficiency	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.50% 5/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint instability	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Ligament laxity	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Limb discomfort	0.10% 1/991 • Number of events 12 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.87% 9/1039 • Number of events 17 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.61% 6/991 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle twitching	0.50% 5/991 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.67% 7/1039 • Number of events 12 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.91% 9/991 • Number of events 23 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.5% 16/1039 • Number of events 49 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendonitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cognitive disorder	0.40% 4/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Coordination abnormal	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Disturbance in attention	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	15.7% 156/991 • Number of events 336 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	21.2% 220/1039 • Number of events 647 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysarthria	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysgeusia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dyskinesia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Fine motor skill dysfunction	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Head discomfort	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypersomnia	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	1.3% 13/991 • Number of events 16 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 21/1039 • Number of events 31 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Lethargy	2.0% 20/991 • Number of events 36 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 14/1039 • Number of events 34 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Medication overuse headache	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Memory impairment	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Mental impairment	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Migraine	0.91% 9/991 • Number of events 10 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.87% 9/1039 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Mononeuropathy	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuralgia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Paraesthesia	5.3% 53/991 • Number of events 84 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 86/1039 • Number of events 293 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Parosmia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Psychomotor hyperactivity	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Restless legs syndrome	0.50% 5/991 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sciatica	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sedation	0.30% 3/991 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sensory disturbance	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sinus headache	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sleep paralysis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Somnolence	7.8% 77/991 • Number of events 153 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 95/1039 • Number of events 290 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Speech disorder	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Stupor	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Tarsal tunnel syndrome	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Tension headache	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Tremor	0.81% 8/991 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 14/1039 • Number of events 19 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Visual field defect	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Abnormal dreams	0.40% 4/991 • Number of events 8 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.58% 6/1039 • Number of events 23 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Affect lability	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Agitation	0.20% 2/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	0.81% 8/991 • Number of events 12 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.87% 9/1039 • Number of events 9 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Bipolar disorder	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depersonalisation/derealisation disorder	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depressed mood	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.40% 4/991 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Disorientation	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.77% 8/1039 • Number of events 11 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Dysphoria	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Emotional distress	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Enuresis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Euphoric mood	0.50% 5/991 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 11/1039 • Number of events 22 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Fear	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Hallucination	0.50% 5/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Hallucination, auditory	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Hallucination, visual	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Hypnagogic hallucination	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Insomnia	0.50% 5/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.67% 7/1039 • Number of events 10 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Irritability	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Listless	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Major depression	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mental fatigue	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mood swings	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Nervousness	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Nightmare	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Panic attack	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Phonophobia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Restlessness	0.61% 6/991 • Number of events 7 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.48% 5/1039 • Number of events 6 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Sleep disorder	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Calculus bladder	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hypertonic bladder	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Proteinuria	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal pain	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Breast pain	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/845 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 1/887 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Menstruation irregular	0.12% 1/845 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/887 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 21 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal odour	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Blister	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.20% 2/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.20% 2/991 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin burning sensation	0.10% 1/991 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Flushing	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.29% 3/1039 • Number of events 4 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hot flush	0.30% 3/991 • Number of events 3 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 4/1039 • Number of events 5 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.19% 2/1039 • Number of events 2 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Orthostatic hypotension	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Pallor	0.00% 0/991 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 1/1039 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral coldness	0.10% 1/991 • Number of events 1 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1039 • Up to 12 Months All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60