Trial Outcomes & Findings for PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes (NCT NCT00153062)
NCT ID: NCT00153062
Last Updated: 2014-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20332 participants
Primary outcome timeframe
time since randomization; follow-up period is 1.5 to 4.4 years
Results posted on
2014-05-13
Participant Flow
Sept 2003 - July 2006; 695 centres in 35 countries
No screening period
Participant milestones
| Measure |
Aspirin + Extended Release Dipyridamole / Telmisartan
25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
|
Aspirin + Extended Release Dipyridamole / Placebo
25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
|
Clopidogrel / Telmisartan
clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
|
Clopidogrel / Placebo
clopidogrel 75 mg, once daily, tablet / placebo tablet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5086
|
5095
|
5060
|
5091
|
|
Overall Study
COMPLETED
|
4699
|
4689
|
4645
|
4680
|
|
Overall Study
NOT COMPLETED
|
387
|
406
|
415
|
411
|
Reasons for withdrawal
| Measure |
Aspirin + Extended Release Dipyridamole / Telmisartan
25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
|
Aspirin + Extended Release Dipyridamole / Placebo
25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
|
Clopidogrel / Telmisartan
clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
|
Clopidogrel / Placebo
clopidogrel 75 mg, once daily, tablet / placebo tablet
|
|---|---|---|---|---|
|
Overall Study
Death
|
360
|
352
|
369
|
365
|
|
Overall Study
Withdrawal by Subject
|
14
|
30
|
27
|
28
|
|
Overall Study
Lost to Follow-up
|
12
|
20
|
15
|
16
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
1
|
1
|
|
Overall Study
No disposition data available
|
1
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Baseline characteristics by cohort
| Measure |
Aspirin + Extended Release Dipyridamole / Telmisartan
n=5086 Participants
25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
|
Aspirin + Extended Release Dipyridamole / Placebo
n=5095 Participants
25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
|
Clopidogrel / Telmisartan
n=5060 Participants
clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
|
Clopidogrel / Placebo
n=5091 Participants
clopidogrel 75 mg, once daily, tablet / placebo tablet
|
Total
n=20332 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
66.1 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1802 Participants
n=5 Participants
|
1851 Participants
n=7 Participants
|
1817 Participants
n=5 Participants
|
1840 Participants
n=4 Participants
|
7310.0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3284 Participants
n=5 Participants
|
3244 Participants
n=7 Participants
|
3243 Participants
n=5 Participants
|
3251 Participants
n=4 Participants
|
13022.0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 yearsPopulation: Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Outcome measures
| Measure |
Aspirin + Extended Release Dipyridamole
n=10181 Participants
Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
|
Clopidogrel
n=10151 Participants
Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
|
|---|---|---|
|
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
|
916 Participants
|
898 Participants
|
PRIMARY outcome
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 yearsOutcome measures
| Measure |
Aspirin + Extended Release Dipyridamole
n=10146 Participants
Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
|
Clopidogrel
n=10186 Participants
Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
|
|---|---|---|
|
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
|
880 Participants
|
934 Participants
|
SECONDARY outcome
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 yearsPopulation: Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Number of patients with any of stroke, myocardial infarction, vascular death
Outcome measures
| Measure |
Aspirin + Extended Release Dipyridamole
n=10181 Participants
Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
|
Clopidogrel
n=10151 Participants
Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
|
|---|---|---|
|
Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
|
1333 Participants
|
1333 Participants
|
SECONDARY outcome
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 yearsPopulation: Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure
Outcome measures
| Measure |
Aspirin + Extended Release Dipyridamole
n=10146 Participants
Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
|
Clopidogrel
n=10186 Participants
Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
|
|---|---|---|
|
Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
|
1367 Participants
|
1463 Participants
|
SECONDARY outcome
Timeframe: Randomization to final patient contactPopulation: Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.
Outcome measures
| Measure |
Aspirin + Extended Release Dipyridamole
n=7306 Participants
Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
|
Clopidogrel
n=7283 Participants
Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
|
|---|---|---|
|
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
|
125 Participants
|
151 Participants
|
Adverse Events
Aspirin + Extended Release Dipyridamole / Telmisartan
Serious events: 1145 serious events
Other events: 1856 other events
Deaths: 0 deaths
Aspirin + Extended Release Dipyridamole / Placebo
Serious events: 1124 serious events
Other events: 1810 other events
Deaths: 0 deaths
Clopidogrel / Telmisartan
Serious events: 1225 serious events
Other events: 866 other events
Deaths: 0 deaths
Clopidogrel / Placebo
Serious events: 1163 serious events
Other events: 810 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin + Extended Release Dipyridamole / Telmisartan
25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
|
Aspirin + Extended Release Dipyridamole / Placebo
25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
|
Clopidogrel / Telmisartan
clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
|
Clopidogrel / Placebo
clopidogrel 75 mg, once daily, tablet / placebo tablet
|
|---|---|---|---|---|
|
Nervous system disorders
Parkinsonism
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Congenital coronary artery malformation
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Ear pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
13/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.40%
20/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Euthyroid sick syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Goitre
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Hyperaldosteronism
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Hyperthyroidism
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Parathyroid gland enlargement
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Cataract
|
0.24%
12/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Dacryostenosis acquired
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Diabetic retinopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Diplopia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Glaucoma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Keratitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Maculopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Open angle glaucoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Retinal haemorrhage
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Retinal tear
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Retinal vein occlusion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Strabismus
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Uveitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Vision blurred
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Eye disorders
Visual disturbance
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
10/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Aphagia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.14%
7/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Constipation
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
18/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.20%
10/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Duodenitis
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Faecaloma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.26%
13/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
7/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Ileus
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.34%
17/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.34%
17/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Megacolon
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Mesenteric arteriosclerosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Nausea
|
0.26%
13/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oral disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Periodontitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Peritonitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Proctocolitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.14%
7/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Stomach mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Volvulus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
23/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Asthenia
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Calcinosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Cardiac death
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Catheter site haemorrhage
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Chest discomfort
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Chest pain
|
0.88%
44/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.66%
33/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.42%
21/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.60%
30/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Chills
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Death
|
0.78%
39/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.74%
37/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.78%
39/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.68%
34/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Drowning
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Dysplasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Effusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Face oedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Facial pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Fatigue
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Feeling abnormal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Fibrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Gait disturbance
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
General physical health deterioration
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Generalised oedema
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Granuloma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Hernia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Hyperthermia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Hyperthermia malignant
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Hypothermia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Impaired healing
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Influenza like illness
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Malaise
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Multi-organ disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Multi-organ failure
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Non-cardiac chest pain
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Oedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Oedema peripheral
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Pain
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Polyp
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Pyrexia
|
0.30%
15/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Sudden cardiac death
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Sudden death
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Tenderness
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Ulcer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
General disorders
Vestibulitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Cholangitis
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
10/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Jaundice
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Allergic oedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Food allergy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Immune system disorders
Sarcoidosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Abdominal abscess
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Abscess
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Abscess limb
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Abscess oral
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Appendicitis
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Aspergillosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bacteraemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Borrelia infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bronchitis
|
0.22%
11/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bronchopneumonia
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Burn infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Carbuncle
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Catheter related infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Catheter sepsis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Catheter site infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Cellulitis
|
0.18%
9/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Cellulitis pharyngeal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Clostridial infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Cystitis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Device related infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Diverticulitis
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Dysentery
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Empyema
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Endometritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Epidemic vomiting syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Erysipelas
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Gangrene
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Gastritis viral
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
17/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.28%
14/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Gastrointestinal infection
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Genitourinary tract infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Graft infection
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Helicobacter gastritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Hepatitis A
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Hepatitis E
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Herpes zoster
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Infected epidermal cyst
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Influenza
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Joint abscess
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Klebsiella infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Labyrinthitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Lobar pneumonia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Localised infection
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Lung infection
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Malaria
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Mastoiditis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Meningitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Meningitis tuberculous
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Osteomyelitis
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Otitis media
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Paronychia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Parotitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pericarditis tuberculous
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pneumonia
|
1.2%
62/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
1.2%
60/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
1.4%
72/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
1.5%
73/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Purulence
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Pyothorax
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Scrotal abscess
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Sepsis
|
0.34%
17/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.34%
17/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.28%
14/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Septic embolus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Septic shock
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Sialoadenitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Sinusitis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Staphylococcal infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Stitch abscess
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Streptococcal sepsis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Subcutaneous abscess
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Sweat gland infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Tuberculosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Urinary bladder abscess
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Urinary tract infection
|
0.64%
32/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.44%
22/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.80%
40/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.76%
38/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Urosepsis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Viral infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
West Nile viral infection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Infections and infestations
Wound infection
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Eye penetration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Neuromyelitis optica
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
39/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
1.1%
53/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.80%
40/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.98%
49/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
9/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.22%
11/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.18%
9/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Injury
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
10/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Spinal cord injury thoracic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.14%
7/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Acid base balance abnormal
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Alanine aminotransferase increased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Allergy test
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Arteriogram coronary
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Aspartate aminotransferase increased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Aspiration bronchial
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Biopsy lymph gland
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood creatinine increased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood glucose decreased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood glucose increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood potassium increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood pressure decreased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood pressure increased
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood test abnormal
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Blood urea increased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Body temperature increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Creatinine renal clearance decreased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Endoscopic retrograde cholangiopancreatography
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Haemoglobin decreased
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Heart rate decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Heart rate irregular
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Hepatic enzyme increased
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
International normalised ratio increased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Myoglobin blood increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Renal function test abnormal
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Transaminases increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Troponin increased
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Urine output decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Investigations
Weight decreased
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
27/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.44%
22/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Gout
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.16%
8/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
13/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
13/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.38%
19/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hyponatraemic syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.24%
12/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.16%
8/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
28/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.46%
23/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.60%
30/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.68%
34/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.14%
7/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute megakaryocytic leukaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer recurrent
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign muscle neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of eye
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary cancer metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Buccal cavity papilloma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
13/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.28%
14/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Genital neoplasm malignant female
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Neuropathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant recurrent
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraocular melanoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia plasmacytic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.42%
21/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eye
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Paraesthesia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eyelid
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant nervous system neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maxillofacial sinus neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to chest wall
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spleen
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Paresis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleura carcinoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.24%
12/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.32%
16/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pseudomyxoma peritonei
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Parkinson's disease
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm benign
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Balance disorder
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Bradykinesia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Brain mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Bulbar palsy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carotid artery disease
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.52%
26/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.38%
19/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.54%
27/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.40%
20/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Central nervous system lesion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Central pain syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Chorea
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Clonic convulsion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Clonus
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cognitive disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Coma
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Consciousness fluctuating
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Convulsion
|
0.54%
27/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.46%
23/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.52%
26/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dementia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dizziness
|
0.32%
16/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.38%
19/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dysarthria
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dysphasia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dysstasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Encephalopathy
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Epilepsy
|
0.36%
18/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.28%
14/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.32%
16/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Facial palsy
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Facial paresis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Grand mal convulsion
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Headache
|
0.42%
21/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.32%
16/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hemiparesis
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hypersomnia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
IVth nerve paralysis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Lateral medullary syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Lethargy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Loss of consciousness
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Mental impairment
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Migraine
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Motor neurone disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Multiple system atrophy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Muscle spasticity
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Myasthenia gravis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Nervous system disorder
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Partial seizures
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Pneumocephalus
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Presyncope
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Radial nerve palsy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Radiculopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Sciatica
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Senile dementia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Simple partial seizures
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Somnolence
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Spinal cord disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Syncope
|
0.50%
25/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.40%
20/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.62%
31/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.48%
24/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Syncope vasovagal
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Tonic convulsion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Tremor
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Ulnar nerve palsy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Vascular dementia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Wernicke-Korsakoff syndrome
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Aggression
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Agitation
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Alcohol abuse
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Alcoholism
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Anxiety
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Confusional state
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Delirium
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Delirium tremens
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Delusion
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Delusional disorder, persecutory type
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Depressed mood
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Depression
|
0.32%
16/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.38%
19/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Depression suicidal
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Homicidal ideation
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Hypomania
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Impaired self-care
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Major depression
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Mania
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Mental status changes
|
0.18%
9/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Nervousness
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Panic attack
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Psychotic disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Sleep disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Somatisation disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Stress
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Suicidal ideation
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Psychiatric disorders
Transient psychosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Anuria
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Azotaemia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Diabetic cystopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Hydroureter
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Incontinence
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Kidney enlargement
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Nephritis autoimmune
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Nephritis interstitial
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Perinephric effusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Pollakiuria
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Proteinuria
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Pyelectasia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Pyuria
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal colic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal cyst
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal embolism
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal failure
|
0.16%
8/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.22%
11/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal failure acute
|
0.66%
33/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.48%
24/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.64%
32/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Renal mass
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Residual urine
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Single functional kidney
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urethral polyp
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
6/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.18%
9/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.34%
17/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Breast microcalcification
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Prostatism
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Reproductive system and breast disorders
Varicocele
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.42%
21/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.34%
17/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.28%
14/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.26%
13/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal leukoplakia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.24%
12/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.16%
8/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Segmented hyalinising vasculitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Social circumstances
Cardiac assistance device user
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Social circumstances
Elderly
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Social circumstances
Social problem
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Angioplasty
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Blepharoplasty
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Plasmapheresis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Surgical and medical procedures
Splenectomy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Accelerated hypertension
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aneurysm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic embolus
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Aortic stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arterial restenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arteriosclerosis
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Arteritis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Circulatory collapse
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Embolism
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Fibromuscular dysplasia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Haematoma
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Hypertension
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.30%
15/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.38%
19/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.40%
20/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Hypertensive crisis
|
0.14%
7/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.24%
12/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Hypertensive emergency
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Hypotension
|
0.38%
19/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.52%
26/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Intermittent claudication
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.12%
6/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Peripheral ischaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Shock
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Temporal arteritis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Venous stasis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.42%
21/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.50%
25/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.42%
21/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.20%
10/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Anaemia folate deficiency
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
AV dissociation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Angina pectoris
|
0.50%
25/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.36%
18/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.50%
25/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.40%
20/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Angina unstable
|
0.82%
41/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.94%
47/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.92%
46/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.60%
30/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Arrhythmia
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrial fibrillation
|
0.84%
42/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.76%
38/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
1.1%
54/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.94%
47/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrial flutter
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Bradycardia
|
0.16%
8/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.38%
19/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac failure
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.14%
7/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiogenic shock
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiomyopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Conduction disorder
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Coronary artery disease
|
0.28%
14/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.66%
33/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.42%
21/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.62%
31/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Coronary artery restenosis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.18%
9/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.18%
9/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Haemorrhage coronary artery
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
In-stent coronary artery restenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Mitral valve calcification
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
4/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.16%
8/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Myopericarditis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Palpitations
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.06%
3/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Sinus arrest
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Sinus bradycardia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
5/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.10%
5/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.08%
4/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
2/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.02%
1/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.04%
2/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.06%
3/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.00%
0/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.02%
1/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.00%
0/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
Other adverse events
| Measure |
Aspirin + Extended Release Dipyridamole / Telmisartan
25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
|
Aspirin + Extended Release Dipyridamole / Placebo
25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
|
Clopidogrel / Telmisartan
clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
|
Clopidogrel / Placebo
clopidogrel 75 mg, once daily, tablet / placebo tablet
|
|---|---|---|---|---|
|
Nervous system disorders
Headache (leading to permanent discont. of study medication)
|
6.3%
318/5013 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
5.6%
280/5024 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
0.84%
42/5000 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
1.00%
50/5023 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Dizziness or lightheadedness (Solicited question at Day 7)
|
15.1%
768/5086 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
11.7%
597/5095 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
10.1%
510/5060 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
7.8%
398/5091 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
|
Nervous system disorders
Headache (Solicited question at Day 7)
|
29.8%
1515/5086 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
30.5%
1556/5095 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
9.7%
491/5060 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
10.7%
546/5091 • From day of first dose until 28 days after last dose
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER